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U.S. Department of Health and Human Services

Class 2 Device Recall Nexcare High Performance Gauze Pad

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  Class 2 Device Recall Nexcare High Performance Gauze Pad see related information
Date Initiated by Firm February 09, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 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/
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 2
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.