"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

"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"

courtesy www.free-animations.co.uk.com  

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

"Triad Sterile Lube Not So Sterile-Just Like Triad Alcohol Products: Check Your Brand Here" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Triad Not-So 'Sterile' Lubricating Jelly

Dear Ones:
         Once in a while we come across a 'recall situation' that is so NOT forth-coming and disclosive that it fairly begs for continued, intense scrutiny.
     Such is the case with Triad Products.
     My main focus of concern at this time is Triad's 'Sterile Jelly' Recall, which received very little press to date, but which demands greater scrutiny now, in my opinion.
      Just for the record, here is their company 'recall page':
LINK: http://www.triad-group.net/index.php?option=com_content&view=section&layout=blog&id=1&Itemid=58
     And here is the link for all FDA notices related to 'Triad Group Recalls':
LINK: http://google2.fda.gov/search?q=triad+group+recalls&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&x=8&y=13
     (If you use the above, be sure to 'refresh' the search tool embedded in it.)
     The Triad lube jelly link is dated way back to this past December 23, 2010
LINK: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm243399.htm       Triad's so-called 'sterile lube jelly' is used to lubricate everything from catheters to fingers, endoscopes and other medical instruments.
     BRANDS AFFECTED BY TRIAD'S STERILE LUBE JELLY RECALL:
     According to Triad, itself, the following 'brand names' are involved in this lube jelly recall:

Triad

Cardinal

Novation

McKesson

Imco

Select

Schein

     A cursory examination of Triad's 'products recall page' reveals that the company is not very 'forthcoming' with information, except to identify the products involved:
Triad Group, Triad Sterile Lubricating Jelly

Recall Class: Class II
Date Recall Initiated: December 23, 2010
Products: Sterile Lubricating Jelly, packaged in:
5 gram tubes
2 ounce and 4 ounce tubes
4 ounce bottles
3 and 5 gram packets
This recall affects all Triad lubricating jelly packages with lot numbers beginning with the numbers 7, 8, 9, or 0. If these packages are part of kits, packs, or trays, the lot numbers will only appear on the lubricating jelly packages.
The Triad lubricating jelly products were distributed by Triad from January, 2007 through December 2010. These products may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.
FDA will update this webpage when additional information is available.
The following table provides brand names, distributors, and product identifiers (catalog or reorder numbers) known at present:
BRAND NAMES FIRM NAMES CATALOG/
REORDER #s PRODUCTS
Allegiance Cardinal Health LJT2
LJF3
LJT4
LJT5 Net Wt. 2 oz.
Net Wt. 3g
Net Wt. 4 oz.
Net Wt. 5g
Select Medical Products PSS World Medical, Inc. 137
136 3g/packet
4 oz.
Novaplus Novation, Inc. V10-8344
V10-8919
V10-8917 Net Wt. 3g
Net Wt. 4 oz.
Net Wt. 2 oz.
Triad
Triad Plus Triad Group, Inc. 10-8917
10-8946
11-8344
11-8472
10-8919
10-8500 Net Wt. 2 oz.
Net Wt. 5g
Net Wt. 3g
Net Wt. 5g
Net Wt. 4 oz.
Net Wt. 4 oz.
IMCO Independent Medical Co-op, Inc. 8919-IMC Net Wt. 4 oz.
McKesson Medi-Pak
Performance McKesson Corporation,
McKesson Surgical 66-8919 Net Wt. 4 oz.
Henry Schein Henry Schein, Inc. 104-9637 Net Wt. 4 fl. oz.
Under Useful Links below, see also firm recall letter and recall webpage, related FDA News Release on non-sterile alcohol prep pads, and related firm Press Releaseon Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks.
Use: This product helps to provide easy insertion of a medical device (such as a catheter or an endoscope) or gloved fingers into body openings.

Recalling Firm:
H & P Industries, Inc., doing business as, Triad Group
700 West North Shore Drive
Hartland, Wisconsin 53029-8358
Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
Public Contact: Customers with questions may contact Triad Group Customer Service at 1-262-538-2900 ext. 2761, Monday through Friday, from 8:30 AM through 4:00 PM, Central Time or your distributor.
FDA District: Minneapolis
FDA Comments:
On December 22, 2010, the company sent an “Urgent Medical Device Recall” letter to all its customers by certified mail. The letter described the issue, identified the affected products with the lot numbers beginning with the digits 7, 8, 9, or 0, as well as the action to be taken by the customers.
Triad Customers (Distributors, and kits, packs, or trays’ manufacturers) were instructed to:
IMMEDIATELY EXAMINE their inventory.
QUARANTINE only lubricating jelly products.
IMMEDIATELY NOTIFY their customers if the recalled product was further distributed.
COMPLETE AND RETURN the enclosed Recall Acknowledgement form by FAX at 1-262-538-2947 or mail to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Harland, Wisconsin 53029, OR
RETURN the recalled product to the appropriate company, if not the Triad Group.
Additional Information:
Triad sterile lubricating jelly products have been incorporated into a variety of procedural and convenience kits, packs, or trays with other medical devices and/or drug products.
Healthcare facilities: IMMEDIATELY CONTACT your kit, pack or tray suppliers to determine whether the products stocked at your facility are impacted by the Triad recall. Your supplier should provide you with documentation on whether your products are affected by the recall.
FDA is instructing manufacturers and repackers who have incorporated the recalled products into their kits, packs or tray to PROMPTLY CONDUCT A SUB-RECALL and submit their recall strategies to their FDA District Office.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.
Useful Links:
Triad Recall Letter 23
Triad Recall Webpage4 5
FDA News Release - Safe Use of Non-Sterile Alcohol Prep Pads 6
Firm Press Release on Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks 7  

Foley Catheters which require the use of a 'sterile lubricating gel'

      We get a somewhat better 'handle' on what may be going on with Triad's lube jelly by reading it's "URGENT MEDICAL RECALL LETTER" dated last Dec. 22, 2010:
"This is to inform you of a product recall involving Sterile Lubricating Jelly distributed by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products. We are initiating this recall because use of inadequately sterilized product might result in patient infection.
LINK: http://www.triad-group.net/media/pdf/LJ_Recall_Ltr_FINAL.pdf

     That which is highlighted above is quite an understatement, since Triad products have been implicated in a number of very serious Bacillus cereus infections (see alcohol pads, swabs and swabstick articles.)
     But, to date, we can find scant information on exactly what kind of 'contamination' affects the recalled Triad lube jelly.

     My advice to you, dear Readers, is to REFRAIN FROM USING TRIAD PRODUCTS, since clearly The Triad Group has a number of 'sterilization issues' with a number of it's products.
     Until more information is released by both Triad, itself, the FDA, private laboratories and third-party witnesses and 'discoverers', it is wise to be cautious.
     Do not depend upon either a commercial manufacturer NOR a government agency to look out for your health!
     Check back here regularly to read the latest.  Just click on the 'Triad Page' on the right.
     Or better yet, sign up to receive Rev. Barb's FREE HEALTH NEWSLETTER.  See details at page bottom.
     And, as always, consult with your personal health care advisor to get the very best input on protecting your health and that of your loved ones.
Blessings,
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com