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Terminated

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.

FDA Recall Z-1234-06 · Posted 2006-07-13

Recalling Firm3M Company / Medical Division
Recall StatusTerminated
Product CodeFRL
Date Initiated2006-02-09
Date Terminated2007-01-05
Product Quantity432 boxes

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, with distributors in CA, LA, MI, NJ, OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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