Smith & Nephew IV Prep Antiseptic Wipe Recall Issued

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.

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.