3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Ca
FDA device recall Z-1234-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- 3M Company / Medical Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRL
- Quantity affected
- 432 boxes
- Distribution
- Nationwide, with distributors in CA, LA, MI, NJ, OH.
- Date initiated
- 2006-02-09
- Date posted
- 2006-07-13
- Date terminated
- 2007-01-05
- Location
- South St Paul, MN
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