Smith & Nephew has halted all shipments of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. All customers and patients are advised to discontinue use of IV PREP Antiseptic Wipes immediately, as their use could result in localized or systemic infection. All customers should dispose of or return IV PREP Antiseptic Wipes to Smith & Nephew.
Smith & Nephew is advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of their kit components to discontinue use of IV PREP Antiseptic Wipes immediately, and issue a sub-recall to their customers.
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. IV PREP Antiseptic Wipes represent a small part of Smith & Nephew’s overall advanced wound management business.
As a precautionary measure, and out of concern for patient safety, Smith & Nephew contracted an independent laboratory to test all lots of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. The results showed there is no data to suggest that Smith & Nephew’s IV PREP Antiseptic Wipes have been compromised. To date, there have been no reported adverse events related to this voluntary recall.
Smith & Nephew is committed to providing customers with high quality, reliable product and has issued this voluntarily recall as a prudent, cautionary and conservative measure to assure patient safety and product performance. Smith & Nephew is working closely with the U.S. Food and Drug Administration (FDA) on this recall.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/Recalls/ucm239219.htm. If you have additional questions regarding Smith & Nephew IV PREP Antiseptic Wipes, please contact the Smith & Nephew Customer Care at 1-800-876-1261 8:00 AM EST to 6:00 PM EST.