More <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">potentially-tainted medical products made by Triad Group of Wisconsin are being recalled because of potential bacterial contamination. The newly-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 sold by Smith & Nephew Inc.
The products being recalled by Smith & Nephew are widely used by diabetics and others who require daily medication. The affected product codes are 420400, 420471, 59420425, 403100, 402300, 59403125 and 59420600. According to a letter from the company, the recall was issued as a precautionary measure, and testing on some products already distributed or quarantined has detected no contamination.
Over the past few months, Triad Group has issued several massive recalls of tainted alcohol prep pads, alcohol swabs, alcohol swabsticks, and other products, sold under various brand names, because of potential contamination because of potential bacterial contamination. Triad Group, along with its parent firm, H&P Industries, has also been named in at least three lawsuits that claim the tainted products caused serious injuries and deaths. One of the lawsuits blames tainted Triad wipes for the death of a 2-year-old boy. That suit claims the wipes were the likely source of bacterial meningitis that killed the child.
According to MSNBC, the U.S. Food & Drug Administration (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.
Earlier this month, U.S. Marshals raided the H&P/Triad facility in Wisconsin and seized more than $6 million in medical supplies made by the companies. A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials.
The raid followed the FDA’s most recent inspection of the facility, which found multiple violations of good manufacturing regulations, including continuing problems with the air handling system; failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.
The FDA had earlier asked H&P Industries to stop manufacturing and distributing products because of the problems found during the March 28 inspection, but it did not comply. H&P Industries finally shut down operations shortly after the U.S. Marshalls descended on the plant. H&P officials, however, characterized the shutdown as â€œvoluntary.â€