Smith & Nephew Recalls IV PREP Antiseptic Wipes for Possible Bacterial Contaminati

Smith & Nephew’s Advanced Wound Management division just announced a U.S. voluntary nationwide recall of selected lots of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">IV PREP Antiseptic Wipes (product number 59421200) that were manufactured by The Triad Group.

This recall follows a prior nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes, and swabs over concerns about potential microbial contamination with Bacillus cereus. Use of the recalled, contaminated alcohol prep pads, wipes, and swabs could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

Smith & Nephew announced that halted all shipments of IV PREP Antiseptic Wipes manufactured by The Triad Group and is advising all customers and patients to discontinue use of the recalled IV PREP Antiseptic Wipes immediately because use of these products could result in localized or systemic infection; customers and patients are advised to dispose of or return the recalled, contaminated IV PREP Antiseptic Wipes to Smith & Nephew. Smith & Nephew is also advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of kit components to discontinue use of the recalled wipes immediately and to issue a sub-recall.

The specific lot numbers involved in the recall are: 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213.

Smith & Nephew contracted an independent laboratory to test all lots of the IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. The results revealed no data to suggest that the IV PREP Antiseptic Wipes were compromised and, to date, no reported adverse events related to this recall have been reported.

Meanwhile, we recently reported that tainted alcohol swabs made by Triad group are being named in medical device litigation concerning the wrongful death of a toddler. As we reported previously, the products were involved in a medical device recall of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad Group over concerns with Bacillus cereus contamination.

The original recall notice, as we’ve written, involved Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks used to disinfect skin prior to an injection and can be identified by “Triad Group,” listed as the manufacturer; the products are also manufactured for a third party and use the following names in the packaging: Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, and Conzellin. The Medical Device Recall affects products marked as STERILE as well as non-sterile products.

Some drug makers issued their own warnings, such as Pfizer Inc.; Merck & Co.; Progenics Pharmaceuticals Inc, a partner of Pfizer, GlaxoSmithKline PLC; Roche Holding AG; Bayer AG; Teva Pharmaceutical Industries Ltd. because, while their medications were not contaminated, the Triad pads, swabs, or swabsticks included in the medications’ packaging—for various different medications—were part of the recall.

Further information on the Triad recall can be accessed on the U.S. Food and Drug Administration (FDA) website at http://www.fda.gov/Safety/Recalls/ucm239219.htm. Smith & Nephew Customer Care can be reached, toll-free, at 1.800.876.1261 from 8:00 a.m. to 6:00 p.m. Eastern Standard Time.

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