Recall Z-1234-06 ยท FRL Fiber, Medical, Absorbent
3M Company / Medical Division
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.
| Date | Jul 13, 2006 (initiated Feb 9, 2006) |
| Status | Terminated |
| Reason | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product. |
| Root 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 | 432 boxes |
| Distribution | Nationwide, with distributors in CA, LA, MI, NJ, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.