Smith & Nephew IV Prep Antiseptic Wipe Recall Issued

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Smith & Nephew has recalled several lots of its antiseptic wipes because they were manufactured by Triad Group, which has already issued a recall for millions of alcohol wipes and swabs due to bacterial contamination and sterility problems. 

The Smith & Nephew IV PREP Antiseptic Wipes recall was announced on March 5, by the FDA and Smith & Nephew. The recall comes about two months after the first Triad alcohol prep pads and swabs were pulled from the market due to the risk of Bacillus cereus contamination.

Smith & Nephew’s Advanced Wound Management division has hired a third party laboratory to test all lots of the IV PREP antiseptic wipes that were manufactured for the company by Triad, and so far the company indicates that no contamination has been detected. However, a recall of the products was issued after information has come to light suggesting that Triad’s sterility process has had systemic problems for years, which could compromise the safety of its products.

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The recall affects 17 lots Smith & Nephew IV PREP Antiseptic Wipes with a product number of 59421200. The lots affected by the recall include: 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, and 1A213.

A Triad alcohol prep pad recall was issued in January, due to potential risk that the wipes were contaminated with bacteria that could cause serious and potentially life-threatening infections. The alcohol prep pads and wipes were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under variety of other labels, including CVS, Walgreens and Cardinal Health.

Since the Triad recall was announced, the FDA has received at least 100 additional reports from consumers who have had problems with the alcohol prep pads and wipes. Bacillus cereus on the alcohol prep pads could cause skin infection, or if the bacteria is pushed into the skin after the surface is cleaned with one of the wipes, it could result in potentially life-threatening infection.

At least two Triad alcohol wipe lawsuits have been filed in recent weeks, including a Bacillus cereus infection wrongful death lawsuit filed by the family of a two-year-old Houston boy who died after becoming infected by the contaminated alcohol wipes.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.

Tags: Alcohol Prep Pad, Alcohol Swab, Alcohol Wipe, Bacillus Cereus Infection, Triad
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4 Comments

Jill
I used the IV prep wipes and was 8 months pregnant. Right after using them, I was hopsitalized with a high fever and vomitting. After I found out about the infected wipes, I wrote a letter requesting more information from Smith and Nephew and have never heard back from them. How very unprofessional!
william b
I’ve had Type I diabetes for over fifty years which was controlled by daily multiple insulin injections, then by an insulin pump starting in January 2000. Not once in all those years had I experienced an infection at an injection/”quick set” site. In June, 2010, I removed a “quick set” and found a large, painful bump on the IV site; I’d been using Smith & Nephew IV prep antiseptic wipes since January 2000. The spot did not go down; rather, it enlarged. My doctor told me it looked like a staph infection. He took a biopsy, and at a folow-up appointment two days later, notified me that I had MRSA. He also advised me that the MRSA could return. I pondered for almost a year where and how I could have acquired such a dangerous, potentially deadly infection and drew a blank–until I received notice of the antiseptic wipes recall. In contacting Smith & Nephew’s customer service department, I was given evasive answers to my questions regarding the type/s of bacteria prompting the recall. I believe the matter speaks for itself. Smith & Nephew, you’ve forever lost a customer!
William
I am a insulin pump user as well, been one now for just about a year now.I have been contacted by my pump supplier this morning and was told about the iv prep recall. My particular brand of i.v. prep matched some of the lot numbers that are involved in the recall as well. I am half way through a box of these preps. Are there any other known side affects,or any other ailments linked to this recall at all ?
Elizabeth
I was shipped the infected IV prep and have been using it for 6 weeks before by chance I found from an insulin pump trainer that it was infected. After checking the packaging I had at home I called and confirmed that it was part of the bad lot. I had been having skin infections for 6 weeks across my abdomen and could not figure out why I was having so many issues. Upon going to my doctor I was diagnosed with Bacillus Cereus infection of the skin, and given antibiotics. I paid for both the iv prep and the doctor/antibiotics myself, who reimburses me for that and my time and suffering?

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