Uni-solve, Other Smith & Nephew Wipes Recall Issued Due to Bacteria Risk

Smith & Nephew, Inc. is removing a number of brands of medical wipes from the market because they were manufactured by Triad Group, which federal investigators say failed to ensure the sterility of its products.  

The Smith & Nephew wipes recall (pdf) was announced in a letter sent to the company’s customers on April 6 and affects its Remove and Uni-Solve adhesive remover wipes labels, as well as its Skin-Prep, Peri-Prep and No-Sting Skin Prep protective wipes.

The wipes were recalled shortly after federal marshals forced a shutdown of H&P Industries, Inc., which had been doing business as Triad Group and allegedly released several medical products onto the market that were contaminated with harmful bacteria, including tens of millions of alcohol wipes and prep pads recalled earlier this year.

Smith & Nephew, Inc. said that it was conducting the recall because the affected wipes were made at the same Wisconsin facility as the Triad Group products, and not because of any known contamination. New versions of the wipes are already being produced and have tested negative for contamination, according to the letter.

The recall affects Remove Universal Adhesive Remover Wipes, Uni-Solve Adhesive Remover Wipes, Skin-Prep Protective Wipes, Peri-Prep Protective Wipes and No-Sting Skin-Prep Protective wipes. The recalled wipes have product code numbers of 420400, 420471, 59420425, 403100, 402300, 59403125 and 59420600.

The company told its customers to notify patients to stop using the wipes immediately and seek a replacement product. The company is only accepting returns from customers who have an account with them. In March, Smith & Nephew similarly issued an IV antiseptic wipes recall because they too had been made at the Triad Group facility.

This recall is the latest in a string of medical device and medical product recalls stemming from alleged poor manufacturing procedures at H&P/Triad Group which caused an outbreak of bacterial contamination late last year and early this year.

H&P, doing business as Triad Group, issued an alcohol wipes recall in early January 2011, after it was discovered that tens of millions of prep pads, swabs and swabsticks tainted with the bacteria Bacillus cereus may have been distributed to consumers. The alcohol prep pads and swabs were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under a variety of other labels, including CVS, Walgreens and Cardinal Health.

The company was also forced to recall sterile lubricating jelly and povidine iodine prep pads due to the risk of contamination.

The initial recall for the alcohol wipes, swabs and pads was not issued due to the prior FDA inspections, but rather after an investigation by The Children’s Hospital in Colorado found that two thirds of the Triad prep pads it had in stock were contaminated and likely caused some children to contract a hospital infection.

There have been at least three Triad alcohol prep pad lawsuits filed against the manufacturer in recent weeks; one by the parents of a two-year-old Houston boy who died due to a Bacillus cereus infection, another by a Tennessee man who alleges that a Triad alcohol prep pad infection left him permanently disabled, and a third that was filed by a 31-year-old Colorado woman with multiple sclerosis who alleges she contracted a life-threatening infection. The parents of a 10-year-old boy with leukemia who fell ill at The Children’s Hospital have also said they intend to file a lawsuit.