Showing posts with label alcohol pads. Show all posts
Showing posts with label alcohol pads. Show all posts

Friday, March 25, 2011

"UPDATE: A Biochemist's Comprehensive INTERNATIONAL LIST Of Triad Alcohol Products Recalled By FDA Due To Bacterial Contamination Concerns" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Some of the Triad (H & P Industries) Alcohol products recalled due to bacterial contamination
Dear Ones:
     Herewith is an updated international list of all the 'brand names' of TRIAD aka H & P Industries ALCOHOL PADS, SWABS and SWABSTICKS potentially contaminated with Bacillus cereus as of 3/25/11.
     This recall affects Canada, the US and Europe.
     Please check and see if the alcohol prep pads, swabs and swabsticks you may have in your possession have any of the brand names here and DO NOT USE THEM!
Allegiance
Best Choice
Boca
Care One
Conzellin
Cooper Atkins
CVS
Discount Drug Mart
Equaline
Equate
Exchange Select
Exact
Good Neighbor
Good Sense
Healthcare
Healthy Generations
Jean Coutu
Katz Group
Kroger
Leader
Life Brand
Loblaw
Longs
Major
MEIJER
Medicine Shoppe
Moore Medical
Personelle
PharmaChoice
PharmaPlus
Premier Value
PSS Select 
Publix
Premier Value
Quality Choice
Rite Aid
Reli-On
Remedy RX
Rexall
Safeway
Shoppers Drug
Shoppers Drug Mart 
Sunmark Top Care
Triad
Triad Sterile
Ultilet
Uniprix
Up&Up
Valu Plus
VersaPro
Western Family
Walgreens
     Read Triad's (H & P Industries) letter here:
LINK: http://www.triad-group.net/media/pdf/Recal_Facts.pdf

     And this is the FDA LINK for injectable kits affected by this Triad FDA Recall.
     Is your drug listed? (see highlights below)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

[UPDATED 03/23/2011] Eli Lilly and Company notified customers not to use Prep Pads in black starter kits for Forteo [teriparatide (rDNA origin) injection].
[UPDATED 03/09/2011] Smith & Nephew issued a recall of IV PREP Antiseptic Wipes, manufactured for Smith & Nephew by The Triad Group.
[UPDATED 02/11/2011] Triad Alcohol Prep Pads are packaged with devices manufactured by Neuro Resource Group. The Triad alcohol prep pads should not be used.
[UPDATED 02/07/2011] Triad Alcohol Prep Pads are a component of Extavia (interferon beta 1-b) packaging marketed by Novartis. The Triad alcohol prep pads should not be used.
[UPDATED 02/05/2011] Triad Alcohol Prep Pads are a component of a convenience kit distributed with Watson’s Trelstar (triptorelin pamoate for injectable suspension) product. The Triad alcohol prep pads should not be used.
[UPDATED 02/01/2011] FDA reminded healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.
[UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be used.
[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the defective Triad alcohol pad. Relistor sold in single vials also is unaffected by this recall. Pfizer and Progenics advise patients using the Relistor kit not to use the Triad alcohol prep pads included in the Relistor packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their Relistor injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.
[UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States. Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.
Bayer is instructing patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.
[UPDATED 01/14/2011] The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall.
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

Tuesday, March 22, 2011

"Triad Povidone Iodine Prep Pads Recalled As Triad Alcohol Pads Have Been Due to Potential Bacterial Contamination-See The Brands List Here" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

see this link for more pkg photos: http://www.fda.gov/Safety/Recalls/ucm247683.htm 
Dear Ones:
     First TRIAD aka H & P INDUSTRIES has a problem with their alcohol prep pads, swabs and swabsticks, and now they have a problem with their povidone iodine prep pads.
     The offending organisms in the case of the alcohol prep products thus far have been Bacillus cereus.
      The offending organism in the case of the povidine iodine prep pads is a different one, specifically Elizabethkingia meningoseptica (pron: el-IZ-a-beth-KEEN-gee-ah   men-IN-joe-SEP-ti-ka.)
     It doesn't help that the FDA website has a major problem with getting something as simple as 'PRODUCT IDENTIFICATION SPELLING CORRECT', and repeatedly, at that!!!
     Also, the FDA's LIST of affected BRANDS--as with the Triad Alcohol Prep Products and Triad Lube Jelly Products is WOEFULLY INSUFFICIENT.
     In an attempt to partially remedy this, I have compiled the list of affected Povidone-Iodine products affected as best as I can.
     And I have 'sic'd' the incorrect spellings in the FDA text for you, as well.
     Ordinarily, I don't give a 'hoot' about innocent misspellings, but these TRIAD Recalls are a whole different story.
     In the disciplines of chemistry and microbiology where every single letter, number, symbol and syntax makes a great deal of difference, I find it unconscionable that I keep finding such shoddy FDA Recall Notice work offered to the American public!
     And we are talking about HUMAN LIVES HERE, such as that of precious Harrison Kothari who lost his life due to sepsis with the organism B. cereus.
LINK: http://http://dearoneshealingministry.blogspot.com/p/triad-alc-pad-fda-recall.html 
     Perhaps I've reached this point of aggravation having encountered TWO instances today alone of GROSS FDA INCOMPETENCE in putting out their 'blurbs'.
See LINK: http://dearoneshealingministry.blogspot.com/2011/03/eli-lilly-forteo-starter-kits-recalled.html 
     In the case of the povidone-iodine prep pads here, I cannot imagine the absolute outrage and despair parents will be forced to endure when they learn of the cavalier attitude of the FDA, should their NEWBORNS DIE due to bacterial meningitis caused by Elizabethkingia meningoseptica!
     DOES ANYONE CARE?
     Anyway, look for these brand names and I will update the list as I can.  And be sure to pass this along:
Allegiance
Amerinet Choice
Cardinal Health
Medical Specialties
North
Novaplus
Novation
Total Resources Int'l
Triad
Triad Plus
North Safety
Total Resources
VERSA Pro
VHA
PHOTO LINK FOR SOME OF THE AFFECTED PRODUCTS:
http://www.fda.gov/Safety/Recalls/ucm247683.htm
     I have attempted to gather all the brand names affected, but do not be complacent if you have a brand of povidone-iodine prep pad product not listed here.
     Be sure to read my regularly updated 'TRIAD RECALL PAGE':
LINK:  http://http://dearoneshealingministry.blogspot.com/p/triad-alc-pad-fda-recall.html 
     Also, you may email your questions and comments to me at BarbaraKSexton@aol.com and check in here regularly: http://www.dearoneshealingministry.blogspot.com/ for other news and updates.
     If you wish to receive my FREE NEWSLETTER and get updates such as this delivered directly to your mailbox, see details at far bottom of this page.
     But whatever you do, do NOT trust the written word alone and be sure to consult your personal health care provider for specific advice for you and your loved ones.
     I'm providing this as a 'public service' with the caveat that everyone be sure to act as 'health advocate' for themselves and for those they care about.
May God Bless You This Day & Always
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/
NOTE:  Below is a verbatim transcript of what is on the FDA Recall Website.  'SIC' notations in red are MINE-Rev. Barb
H&P Industries, Inc. Issues a Voluntary Nationwide Recall of All Lots of Povidine (sic) Iodine Prep Pads Due to Potential Microbial Contamination

FOR IMMEDIATE RELEASE — March 15, 2011 —Hartland, Wisconsin, H&P industries, Inc., a manufacturer of over-the-counter products has initiated a voluntary product recall of ALL LOTS of POVIDINE (sic)PREP PADS manufactured by H&P Industries, Inc. but which are private labeled for many accounts. This recall has been initiated due to results of the FDA’s ongoing investigation and sampling efforts, and H&P Industries, Inc. internal investigation.

The Povidine (sic) Iodine Prep Pads are non-sterile and contain some of the same raw material as the recalled Alcohol Prep pads, and were therefore investigated by FDA and by H&P Industries for potential contamination with objectionable organisms. However, analytical testing showed the presence of objectionable organisms, namely Elizabethkingia meningoseptica.
We are therefore taking immediate action to voluntarily recall the Povidine (sic) Iodine Prep Pads. Use of contaminated Povidine (sic) Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections. To date we have not received any reports of adverse events.
Povidine (sic) Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets. The affected Povidine (sic) Iodine Prep Pads can be identified by the names listed below in their packaging:
Cardinal Health
Medical Specialties
VHA
Triad
Triad Plus
North Safety
Total Resources
These products were distributed in the United States. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession, they should not use the product and should return it to the place it was purchased for a full refund or call H&P Industries, Inc. Customer Service Monday through Friday between the hours of 8:30 a.m. and 4:00 p.m. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call H&P Industries, Inc. Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.html  
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2 . Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.
LINK for above in black: http://www.fda.gov/Safety/Recalls/ucm247658.htm 
Note from Rev. Barb:
"(sic)" means that something is quoted just as it first appeared.  It is used in cases where the writer wishes her readers to know that no 'translation errors' have been made by her in presenting the quoted text. In the case above, there IS no such 'thing' known as 'povidine', as the FDA puts it.  Anyone with the LEAST amount of actual experience in the field of biomedicine would--or should-- catch this and similar 'gross errors' immediately, while laymen might never know the difference unless a health care professional brings it to their attention--such a despicable state when innocent lives are at risk and lost.
http://en.wikipedia.org/wiki/Sic

"Eli Lilly 'FORTEO' Starter Kits Recalled Due To Triad Alcohol Pads Potentially Contaminated With Bacillus Cereus" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Lilly Announces Important Action Regarding Recall
of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits
This Recall Does Not Affect or Involve Forteo Delivery Device
Dear Ones:
     The Triad Alcohol pad recall situation continues to evolve.
     Now FORTEO (black) patient starter kits are involved since they include alcohol prep pads made by Triad.
     FORTEO is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for:
---Treatment of postmenopausal women with osteoporosis at high risk for fracture
---Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
---Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
     In English, this means that FORTEO is a synthetic parathyroid hormone-like compound which is used to encourage bone growth in the body.

"FOR IMMEDIATE RELEASE - March 17, 2011 - INDIANAPOLIS, March 17, 2011 – Eli Lilly and Company (NYSE: LLY) announced today that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States. The Tri-ad (sic) Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus (sic) cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device.
---Treatment of postmenopausal women with osteoporosis at high risk for fracture
---Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
---Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
     In 'English', this means that FORTEO is a synthetic parathyroid hormone-like compound which is used to promote bone growth.
     It is administered by injection via a 'multi-dose' device, hence the need for alchol pads.
Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
Some Forteo starter kits distributed by Eli Lilly and Company between March 2008 and June 2009 may have contained Triad Group alcohol prep pads. The Triad alcohol prep pads should not be used. The Forteo starter kits that contained the Triad alcohol prep pads were black bags and were discontinued in June 2009. The Forteo starter kits have been updated since June 2009. The bags are now blue, do not include Triad alcohol prep pads, nor any other alcohol prep pad.


Lilly has requested that physicians and their staff examine their inventory of Forteo starter kits and remove and appropriately discard the Triad Group alcohol prep pads in the black bags. Lil-ly has also requested that physicians inform any patients who may have received Forteo starter kits containing Triad Group alcohol prep pads to discontinue use of the pads.
Further information about this recall can be found at http://www.fda.gov/Safety/Recalls/ucm239219.htm1  For questions pertaining to the recall, consumers may contact Triad Group at 262-538-2900.


Adverse reactions or quality problems experienced with the use of the Triad alcohol prep pads may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm2
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm3
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 Fax: 1-800-FDA-0178
READ THE REST HERE: http://www.fda.gov/Safety/Recalls/ucm247596.htm
     And be sure to read all of my articles to date on the TRIAD ALCOHOL PREP PAD/SWABS/SWABSTICK Recall:
LINK: http://dearoneshealingministry.blogspot.com/p/triad-alc-pad-fda-recall.html
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

Saturday, March 12, 2011

"Triad 'Sterile' Lube Jelly FDA Recall Affects Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates As Well As The U.S.A." By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Triad 'Sterile' Lube Jelly
Dear Global Readers:
     The Triad 'Sterile' Lube Jelly FDA Recall affects many all across the globe, as listed below:
"Worldwide distribution: USA including states of: CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MY, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI and Puerto Rico; and countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates."
LINK:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=96796&CREATE_DT=2011-01-21
     Brand Names affected include:
     Allegiance
     Cardinal Health
     Select Medical Products
     PSS World Medical, Inc.
     Novaplus
     Novation, Inc.
     Triad
     Triad Plus
     Triad Group, Inc.
     IMCO
     Independent Medical Co-op, Inc.
     McKesson Medi-Pak
     Performance
     McKesson Corporation,
     McKesson Surgical
     Henry Schein
     PLEASE BE SURE TO READ MY CONSTANTLY UPDATED 'TRIAD' PAGE WITH A LIST OF ALL THE ARTICLES I HAVE WRITTEN ON RECALLS OF TRIAD'S ALCOHOL AND 'STERILE' LUBE JELLY PRODUCTS.
     Here's the TRIAD PAGE LINK:
http://dearoneshealingministry.blogspot.com/p/triad-alc-pad-fda-recall.html
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

"Unhappy With Your Liposuction Results As Far Back As 2004?-Read Here About A Possible Triad 'Sterile' Jelly Connection" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"


Dear Ones:
     The Triad Alcohol prep pads and swabs and Triad 'Sterile' jelly lube story will just not go away.
     I recently came across a MAUDE Report (Manufacturer and User Facility Device Experience Database) implicating Triad 'Sterile' Jelly Lube in a number of unsatisfactory liposuction results.
      The MAUDE Report is dated 2004, but the page it is on was recently UPDATED on Feb. 28, 2011.
"THE TRIAD GROUP, DIVISION OF H & P INDUSTRIES TRIAD LUBRICATION JELLY LINK: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=611249 
Event Date 06/01/2004  Event Description:
There is an urgent need for fda to investigate a product that is currently being used by plastic surgeons during liposuction procedures that is creating tremendous wound problems that have never been seen before. Between one hundred to two hundred pts have been adversely affected with scarring and infected foreign body reactions from the use of a lubrication jelly produced by triad. The use of triad lubrication jelly started in june 2004 when the johnson and johnson k-y jelly was discontinued. The local distributors substituted the triad brand lubrication jelly. The jelly is used during the liposuction procedure to keep the wound edges from being traumatized by the metal liposuction cannula that moves in and out of the wound several hundred times at a quick pace. Most plastic surgeons started noticing unusual wound healing problems around the incision sites that typically healed without any problems. The healing problems started with severe redness and induration followed by opening of the wound at 2-4 months and chronic drainage with cellulitis in many cases. In all cases the resulting scarring is far worse than the normal small line that forms after liposuction. In dec 2004 a group of plastic surgeons who use the same surgical facility came to the conclusion that the triad gel was the only factor in their procedures that had been changed. This particular group started contacting other plastic surgeons in the ensuring months and several other surgeons reported similar problems in every liposuction pt where the triad jelly was used. At plastic surgery meetings more and more surgeons were reporting this wound healing problem with the only common factor being the triad jelly. Triad was initially contacted by a physician in dec. 2004, but no letters or measures were taken to notify physicians or distributors about the potential problems in using jelly during liposuction. In feb. Of 2005 an official letter from triad was released by their quality control division stating that the jelly had successfully passed all the necessary quality controls and that the triad jelly was similar to other equivalent jelly being used in the market place. Again no letter was issued to physicians or the distributor of the product about the potential problem with this type of usage. There is a list of board certified plastic surgeons who have used triad jelly and have numerous pts in their practices with ongoing wound and scar problems. Reporter has been contacted by pt's attorneys as well as several other physicians who have pending law suits based on infections and scarring. Fda should open an immediate investigation and in the very least have triad circulate a warning to all physicians and distributors of the product. The physicians are willing to cooperate in any way to assist the fda in collecting info in a timely fashion."
     Perhaps this information will be of some help to you.
With Love in Christ
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com 

Triad Sterile Lubricating Jelly

Thursday, February 17, 2011

"Triad Alcohol Swabs Implicated In Houston Toddler's Meningitis Death" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"


LINK:
Triad Alcohol Products-prep pads, swabs & swabsticks
Dear Ones:
     I've been praying something like this would not have to be written. 
     But there is a possibility that a Houston toddler died as a result of Triad alcohol prep products being used on his recent lumbar surgical incision area after cyst removal surgery.
     And it is, in fact, the tragic story of this youngster Harrison Kothari which may have been the case that triggered the Triad alcohol prep pad and swabstick RECALL I've been writing about here on this blog since January 20, 2011.
     Note: LINKS below are listed chronologically:
LINK: http://dearoneshealingministry.blogspot.com/2011/01/contaminated-alcohol-swabs-recalled-in.html
     Here are some additional follow-up articles:
LINK: http://dearoneshealingministry.blogspot.com/2011/01/genentechinjectables-boniva-fuzeon.html
LINK: http://dearoneshealingministry.blogspot.com/2011/01/now-pfizer-progenics-recalling-relistor.html
LINK: http://dearoneshealingministry.blogspot.com/2011/02/neuro-resource-group-issues-recall-due.html
     Below are the heart-wrenching details of the ordeal parents Sandra and Shanoop Kothari went through with their two year old son Harrison:-
----------------------------------------------------------------------------------------------
Company recalls alcohol swabs after Houston toddler's meningitis death "by Leigh Frillici and Courtney Zubowski / 11 News
www.khou.com 
Posted on February 14, 2011 at 6:17 PM
Updated Monday, Feb 14 at 10:46 PM
HOUSTON—Looking at the pictures of 2-year-old Harrison Kothari in his family’s home, you see a smiling, laughing child.
What you’d never know is the little boy had brain surgery a month earlier to remove a benign cyst.
"He was a happy, beautiful 2-year-old boy," said Sandra Kothari, Harrison’s mother. "He loved music, he loved playing with his 7-year-old sister."
Shortly after turning 2, Harrison died during his hospital stay at Children’s Memorial Hermann. At the time, he had a drain inserted in his spine to remove some fluid, and he was set to go home the next day.
"He had healed fabulously," said Shanoop Kothari, Harrison’s father. "He was going to get the drain removed the next day."
That night, the boy developed bacterial meningitis. He died hours later.
The Kotharis believe alcohol swabs made by TRIAD Group, Inc., were to blame. They say the swabs were used to clean their son’s drain. The Kotharis believe the swabs were contaminated with a nasty bacteria called bacillus cereus—more commonly known to cause food poisoning.
"In managing a lumbar drain, they use the swab on the portal," said Jim Perdue, the Kotharis attorney. "And so, it’s pushed in and pulled back out so there is literally an opportunity to have injected this bacillus cereus into the lumbar drain every time they used an alcohol swab."
Triad Group has voluntarily recalled all of its alcohol products. The company also makes alcohol pads and swabs for dozens of other stores, like CVS, Kroger, Safeway and Walgreens.
Perdue says the concerns aren’t just for patients like Harrison, but also for people who use Triad alcohol pads for injections.
They are suing the company."
"It’s a very resistant bacteria (bacillus cereus)," said Perdue. "The body is able to fight it off if you have a healthy person. But when you’re talking about injections for people with M.S. or diabetes and they’re literally using this at the injection site and then puncturing the skin, it can cause some really serious problems."
Houston endocrinologist Dr. Eric Orzeck said if there was in fact contamination, the very young that don’t have as strong as an immune system are particularly at risk.
"When it’s applied to the skin and there’s an open area in which you would use when you’re getting an IV, that can cause a very severe local infection," said Dr. Orzeck.
He says symptoms could develop within 24 hours of using it.  Those who haven’t seen symptoms past two days are probably OK, Orzeck said.
There are several symptoms the doctor says to keep in mind.
"It might be headaches or difficulty breathing, obviously infection at the site which would be apparent with redness and swelling," he said.
What concerns the Khotaris is that most people haven’t heard of the recall.
"People could have these in their homes, in their bathrooms right now," said Sandra Kothari.
And so as painful as it is to talk about their son, the Kotharis hope that people will remember their little boy and do a simple thing—check their medicine cabinets.
Children’s Memorial Hermann Hospital released a statement in response to the tragic news.
"Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care," it read. "Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital."
The manufacturer has not responded to an 11 News request for information, but its website states:
"This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism that may or may not be related to Triad’s manufacture of these products. We are, out of an abundance of caution, recalling these lots and revalidating our production lines…"
LINK: http://www.khou.com/news/local/Company-recalls-alcohol-swabs-after-toddlers-meningitis-death-116197699.html 
-----------------------------------------------------------------------------------------------
     If you haven't already, you may want to sign up for my FREE NEWSLETTER and get the latest news 'explained' and sent right to your email box.  See details below.
     Please have a 'care and a prayer' for this poor grieving Kothari family as we continue to stay on top of the Triad alcohol product FDA Recall.
     And pray for those who manufacture Triad products and for those who manufacture products co-packaged with Triad brand alcohol products.
     It is a worst fear and a nightmare to know that one may be inadvertently, partly or even completely responsible for a tragedy such as the loss of little Harrison Kothari.
God Grant You His Blessings
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com



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"Neuro Resource Group Issues Recall Due To Potentially Contaminated Triad Alcohol Prep Products" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Dear Ones:
   Another company, Neuro Resource Group, has issued a recall of it's medical devices which are co-packaged with Triad brand alcohol prep pads, alcohol swabs and alchohol swabsticks.
     According to Neuro Resource Group's website:
"Neuro Resource Group (NRG) specializes in the development, design and manufacture of innovative medical products for injury management, rehabilitation, and pain management. The Company's management team has extensive experience in the healthcare industry and is committed to providing products and developing training materials and protocols that help to improve the quality of patient's lives and also enhance athletic performance on both a professional and non-professional level."
LINK: http://www.nrg-unlimited.com/index.php/about-nrg.html 
     NRG's medical devices for CONSUMERS include:  
Single Patient Systems: A range of body specific Conductive Garments for home use and

Single Patient Systems: A range of body specific Conductive Garments for home use
(Health Care Professionals, see photos of Professional Devices below)
    
     It is important that everyone NOT USE any TRIAD ALCOHOL PREP PRODUCTS which can be identified by either “Triad Group,” listed as the manufacturer, or the products which are manufactured for a third party and use the names listed below in their packaging:
LINK: http://www.fda.gov/Safety/Recalls/ucm242736.htm
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin
Select
Select Medical Products
PSS Select
PSS World Medical, Inc
     Please note that these Triad alcohol prep products were distributed in the UNITED STATES, CANADA and EUROPE.
     Below is the information on the FDA site:
Informs Customers of Important Information
about Triad Group's Alcohol Prep Pads
Contact:
Sarah Magee
972-665-1810 X231
FOR IMMEDIATE RELEASE - February 7, 2011 -Neuro Resource Group, Inc. (NRG) has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, http://www.fda.gov/Safety/Recalls/ucm239219.htm9 . The Triad Group alcohol prep pads are co-packaged and distributed with NRG devices to customers in the United States and internationally.


According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. The Triad wipes may also be labeled “Select”; “Select Medical Products”; “PSS Select”, or “PSS World Medical, Inc.” The subject Triad/Select alcohol wipes previously provided with NRG devices should be discarded immediately. NRG is currently providing alcohol wipes that are not subject to recall.


It is important to note, that NRG devices are not contaminated and may continue to be used in accordance with the instructions for use. The alcohol wipes were provided strictly as a cleaning convenience. Patients and healthcare providers should not use the Triad/Select alcohol prep pads packaged with these devices and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a gauze or tissue pad in conjunction with 70% isopropyl alcohol for cleaning. For replacement wipes, customers may contact NRG customer service at 1-877-314-6500.

The company plans to issue a letter to customers to make them aware of the Triad product recall and the need to discontinue use of the Triad alcohol prep pads packaged with NRG products. Further information about the Triad Group recall can be found on the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319 .htm10.


Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact NRG Customer Service at 1-877-314-6500 between the hours of 8 am and 5 pm Central Time."

     Please take care if you use these devices. DO NOT USE any TRIAD ALCOHOL PRODUCTS packaged with them.
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"

Wednesday, February 16, 2011

"Biochemist Recommends: Always Request Glove Changes You're Entitled To During TSA Pat-Downs!" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

TSA Pat-Down
Dear Ones:
     Well, I searched for it and here is a link on the TSA website which states that you have every RIGHT to ask TSA Officers to change their gloves when they touch your person and your property.
"You have the right to ask a Security Officer to change her/his gloves during the physical inspection of your accessible property, before performing a physical search (pat-down,) or any time a Security Officer handles your footwear." 
LINK: http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1567.shtm
     I have already discussed contamination and contagion possibilites at the hands of TSA agents
LINK: http://dearoneshealingministry.blogspot.com/2010/11/tsa-luggage-searches-infective.html 
     Regular 'glove changes' are prudent for travelers and TSA Officers alike.
     The only caveat is that since the gloves only cover up to the wrist, it is important to realize that any 'exudates', weeping/oozing fluids, bacteria, viruses, protozoans and so forth entrapped on the sleeves and other uniform parts of the TSA Officers (and on their bare skin for those wearing short sleeves) STILL HAVE THE POTENTIAL TO CAUSE PROBLEMS FOR YOU.
     Should any of the above contaminate you via the TSA Officer's clothes, you may be at risk, especially, should the contaminated uniform make contact with your eyes, mouth, nose, ears, broken skin, mucous membranes, 'rashy areas' and other 'areas'.
     Many microbes can live for an amazingly long time on so-called 'non-living surfaces' like clothing, pens, communication devices, clipboards, 'wands' and all the other items TSA Officers are likely to use when examining you.
     And the contamination potential can be even WORSE when the TSA Agent has bare arms which can carry not only fellow travelers' contamination, but his or her OWN population of bio-organisms, both pathogenic and non-pathogenic, as well!
TSA Pat-Down

     DON'T BE SHY!  ASK FOR A GLOVE CHANGE FOR THE FOLLOWING:
--before anyone handles and inspects your carry-ons
--after anyone handles your shoes and intends to continue
--after a TSA Officer touches their face/nose/mouth/ears/hair or anywhere else on their own body
--after anyone sneezes and/or coughs and/or has a runny nose and/or drools or 'splatters saliva while speaking' during your pat-down
--after a cast or brace is 'swabbed for explosives'.  It is virtually impossible to keep a cast or brace absolutely sterile and the swabbing procedure is essentially a 'microbe-collecting procedure' which will contaminate the TSA Officer's gloves no matter what he or she does.
--any time you feel uncomfortable with sanitation levels during your pat-down.
     Of course, these suggestions are as much for the benefit of the TSA Officers as they are for the traveling public.
     In an ideal world, TSA Officer's would be provided with new, clean disposable cover-ups and multiple sets of gloves for each and every passenger.
     If it were up to me, they would wear face masks, as well.
     But as it stands now, I suppose it will be necessary for some sort of airport and travel-related epidemic to break out before those safe-guards are in place.
     I've already written about 'Dominican Republic/Haitian Cholera' in New York City:
LINK: http://dearoneshealingministry.blogspot.com/2011/02/dohmh-officials-confirm-3-cases-of.html 
And about the emergence of Dengue Fever in the United States:
LINK:  http://dearoneshealingministry.blogspot.com/2010/08/dengue-fever-redux-socio-medical.html
     I also have a word or two for those with allergies.  Certainly, latex gloves themselves have a high allergenic potential for some people. 
     Please be sure to carry a note from your health care provider IF YOU ARE ALLERGIC TO LATEX and request the use of NON-LATEX GLOVES by any TSA Officers patting you down and touching your property.
     For those of you allergic to strong scents, be sure to request a 'glove change' whenever you suspect that a TSA Officer's gloves are contaminated with perfume or any other highly odoriferous substance.
      If the TSA Officer themselves has any overpowering odors themselves which are likely to aggravate your allergies, you may have to ask for a 'TSA Officer change', as well! 
    I imagine TSA Officers are counseled to not wear strong fragrance, etc and if not, they should be. 
     But in the course of the day, it is pretty likely that something or other from some one's Dopp kit will spill on a TSA Officer's clothing or work area, so you must be prepared to advocate for yourself if you or your loved ones have allergies. 
     I pray this information is of some help to you.  Please be sure to read all the 'tips' provided on the TSA Pat-Down Page entitled "Tips For The Screening Process":
LINK: http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1567.shtm
     They're good ones as we attempt to 'cope' with the realities of modern air travel in an uncertain world.
God Bless You & Bon Voyage
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com
BarbaraKSexton@aol.com 

Wednesday, February 9, 2011

"Watson Announces Important Alert Regarding FDA-Recalled Triad Alcohol Pads Packed With Their Prostate Cancer Drug Trelstar" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets The Cross"

TRELSTAR is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The empirical formula is C64H82N18O13 · C23H16O6 and the molecular weight is 1699.9. The structural formula is:

The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials. http://pi.watson.com/data_stream.asp?product_group=1684&p=pi&language=E 
Dear Ones:
     Problems arising from TRIAD alcohol pads and swabs potentially contaminated with Bacillus cereus continue on.  Please note that the manufacturers of all the injectables involved in these recalls maintain that the drugs, themselves, are SAFE!
     It is imperative that patients NOT USE the Triad alcohol prep pads included with injectables, in this case for Trelstar aka triptorelin pamoate for injectable suspension. 
     Trelstar is a form of 'hormone therapy' for prostate cancer.  In the common vernacular, it is an agent of 'chemical castration'. 
     Specifically, Trelstar is a Gonadotropin releasing hormone (GnRH) agonist, which means it 'mimics' natural GnRH  and is capable of 'blocking' GnRH receptors in the brain. 
     (Yes...the 'brain' really IS our major sex organ as I have said many times before, a concept which is finally enjoying the attention it deserves from my 'traditionally-oriented' colleagues.
     See: "Mercury Poisoning Makes Birds Act Homosexual LINK: http://news.nationalgeographic.com/news/2010/12/101203-homosexual-birds-mercury-science/
     Then read my trail-blazing alternative biomedicine 'piece' on how the drugs we take, environmental factors and the food we eat affect likewise affect our 'sexuality'.  LINK: http://dearoneshealingministry.blogspot.com/2010/09/drugs-we-take-in-our-food-which-affect.html )
     Trelstar (or a similar GnRH agonist) 'fools' brain receptors into thinking all of it's GnRH receptors are being 'blocked' by the 'real thing'.
     The pituitary thus becomes 'stimulated' and it's secretion of FSH and LH eventually decreases.  This, in turn, ultimately causes the testes to produce less testosterone, as well as reducing PSA levels.* (please see my note below)
         Many cases of prostate cancer respond positively to efforts to decrease testosterone and this is why Trelstar is as useful as it is as a pharmaceutical option in prostate cancer treatment.
     According to the data Watson shows, Trelstar, in fact, is extremely effective:
"6-month Trelstar 22.5 mg maintains testosterone levels similar to those achieved with surgical castration.     Here are the specifics from the FDA Recalls site:

Mean testosterone level of 12.8 ng/dL in months 2 through 122
97.5% of patients achieved castrate serum testosterone level by day 291
98.3% of patients were below castrate level at month 6 and month 122"
http://www.trelstar.com/hcp-trelstar-22.5-mg.asp

"FOR IMMEDIATE RELEASE - February 4, 2011 -Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

The Company emphasized that there is no potential contamination of the Trelstar product, the MIXJECT® system or components in the Trelstar packaging, other than the Triad alcohol prep pad. The Trelstar drug and the MIXJECT® system have not been affected in any way.

Watson has ceased shipments of Trelstar packaging components that incorporate the Triad alcohol pad while it pursues options to remove or replace the prep pad. Convenience kits will not be available in Trelstar commercial packages until new convenience kits incorporating a replacement alcohol prep pad are available for distribution in March 2011. The Company also noted that it was cooperating fully with the FDA, and notifying its customers.

Watson instructs customers to immediately discontinue the use of the Triad alcohol prep pad included in the Trelstar convenience kit and to appropriately dispose of the entire convenience kit. The Company also recommends customers use an alternative alcohol prep pad product that is not involved with this recall, or to use a sterile gauze pad in conjunction with isopropyl alcohol as an alternative. Both prep pads and gauze should be available at your local pharmacy.

Further information on this Triad alcohol prep pad recall can be found on the FDA website at
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm9
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm10   
• Regular Mail: use postage-paid, pre-addressed Form FDA
3500 available at:www.fda.gov/MedWatch/getforms.htm11
Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178"
LINK: http://www.fda.gov/Safety/Recalls/ucm242359.htm
     The last thing a prostate cancer patient needs is any kind of infection at an injection site, especially with all the hot-flashes you have to contend with. 
     So please take care with the alcohol prep pads you may be using at this time!
     If anything 'good' can be gleaned from this Triad situation, it is this: for once, health care professionals are finally advising that isopropyl alcohol and a sterile gauze pad are all it takes to cleanse an injection site.
      Who knows?  Maybe common sense will prevail and health care cost-savings may be realized in some small way with this Triad alcohol prep pad and swab stick recall.
     Alcohol prep pads are not all that expensive in and of themselves.  But when they are fanci-packed in so-called 'Convenience Kits',  packaging costs can sky-rocket, for patients, hospitals and in this case, for the drug-manufacturers themselves.
     I pray this information is of use to you or someone you love.
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/
*Note: this is a very condensed and abbreviated version of the complicated endocrinology under discussion here. Nothing is straightforward in this particular discipline and there are 'lag-periods', 'surge periods' and various 'weaning periods' for hormonal agents--both synthetic and natural--used in the treatment of hormonally-dependent cancers.  If you have something you would like to have translated from 'medical-ese' into 'English', Rev. Barb may be able to help you if you email her with your general questions at BarbaraKSexton@aol.com
If you would like to subscribe to Reverend Barbara Sexton's newsletter for the Dear Ones Healing Ministry, just send your name and e-mail address to: BarbaraKSexton@aol.com  

Stay current with medical issues from a biochemist's point-of-view. Get tips, alerts and sound advice on the many different healthcare topics that affect you and your loved ones on a daily basis as news breaks. It's FREE, so sign up TODAY, if you are not already receiving this informative and potentially life-saving newsletter.
Please understand that Reverend Barbara Sexton is a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided by her is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice.
DISCLAIMER FOR HEALTH CARE PROFESSIONALS AND THEIR PATIENTS:
Please understand that I am a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided at http://www.dearoneshealingministry.blogspot.com/ and in any emails sent out by BarbaraKSexton@aol.com is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice. You are encouraged to share the contents at http://www.dearoneshealingministry.blogspot.com/ and of any e-mails specifically sent to you by Reverend Barbara Sexton, M.Sc. with your medical doctor and/or other healthcare providers with the understanding that all Intellectual Property Rights belong to Reverend Barbara Sexton, M.Sc. As such, this intellectual property may not be copied, transferred, transmitted, utilized or distributed by or for anyone else without my express permission and in accordance with all applicable laws. Any case-specific e-mails sent out by Reverend Barbara Sexton, M.Sc. are for the individuals for whom they are intended only and are subject to the Intellectual Property Rights restrictions above. Healthcare professionals may contact BarbaraKSexton@aol.com for terms, restrictions and fees (if any) if they wish to utilize this intellectual property for themselves or in their practices. Exceptions: FREE NEWSLETTER RECIPIENTS may share their copies with friends and family. Healthcare Professionals may sign up for the SAME FREE Dear Ones Healing Ministry NEWSLETTER by sending their name, address and email address to Reverend Barbara Sexton, M/Sc. at BarbaraKSexton@aol.com Public Domain: This disclaimer published 3/8/10 on http://www.dearonesministry.blogspot.com/  Updated 2/9/11 All contents copyrighted 2011.

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