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

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