Class 2 Device Recall Nexcare High Performance Gauze Pad

• Date Initiated by Firm: February 09, 2006
• Date Posted: July 13, 2006
• Recall Status: Terminated on January 05, 2007
• Recall Number: Z-1234-06
• Recall Event ID: 34633
• Product Classification: Fiber, Medical, Absorbent - Product Code FRL
• Product: 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.
• Code Information: Lots 6018, 6019
• Recalling Firm/ Manufacturer: 3M Company / Medical Division; 3M Center, Bldg 275-05-W-06; South St Paul MN 55411
• Manufacturer Reason for Recall: After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.
• FDA Determined Cause: Other
• Action: All product in house and at the distributors was put on hold at the time of discovery. Distributors were contacted by telephone between 2/7/06 & 2/8/06 and asked to hold product from affected lots. Recall Letters to distributors dated 2/9/06 were faxed and mailed via UPS next day air on 2/9/06.
• Quantity in Commerce: 432 boxes
• Distribution: Nationwide, with distributors in CA, LA, MI, NJ, OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.