Medical device maker Smith & Nephew Inc. is recalling more products made by the Triad Group Inc. of Wisconsin, saying they could be contaminated with potentially dangerous bacteria.
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The new recall includes two types of products: wipes used to protect the skin before medical tapes and films are applied, and adhesive removers that can clean residues from the skin, according to the firm. The products, including UNI-SOLVE Adhesive Remover Wipes, are widely used by diabetics and others who require daily medication.
The move expands again the recall of products manufactured and distributed by H&P Industries Inc. and the Triad Group Inc. of Hartland, Wis., which have been shuttered by the federal Food and Drug Administration. On April 6, U.S. Marshals seized more than $6 million in medical supplies made by the twin family-owned firms.
An FDA spokeswoman said the agency is aware of the latest voluntary recall.
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H&P Industries products have been cited in at least three lawsuits that blame contaminated alcohol prep pads for serious injuries and a death. In January, H&P Industries launched a recall of all lots of alcohol wipes because of the potential for contamination with Bacillus cereus. The bacteria can cause serious life-threatening infections in ill and vulnerable people. H&P Industries also has issued recalls for lubricating jelly and povidone iodine wipes.
Since early January, the FDA has received 201 reports of problems with Triad alcohol wipes, including allegations of seven deaths, 114 infections and 87 minor problems, such as rashes, according to a summary of the agency's MedWatch reporting system. FDA officials are investigating the deaths; however, only one — a 2-year-old boy — specifically cited Bacillus cereus as the cause. The others did not include a specific organism or cause of death, and FDA officials can't yet say whether they were related to use of the Triad products.
One report identified the growth of Bacillus cereus after a lumbar puncture in a premature baby boy delivered by cesarean section. The child's condition was not reported.
Smith & Nephew is a global distributor of medical products and devices. Like many others, it contracts with firms such as H&P Industries to make some of its products. Mary Heather, a Smith & Nephew spokeswoman, said that company notified the FDA about the new voluntary recall on April 6, citing the potential for contamination with Bacillus cereus.
Testing performed on some products already distributed or quarantined has detected no contamination, but a company letter indicated the firm was launching the recall "out of an abundance of caution."
Recalled products include 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 affected product codes are 420400, 420471, 59420425, 403100, 402300, 59403125 and 59420600. Click here for specific lot numbers.
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