Recall Z-0264-05 ยท FRO Dressing, Wound, Drug
3M Company / Medical Division
3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling.
| Date | Nov 30, 2004 (initiated Nov 5, 2004) |
| Status | Terminated |
| Reason | Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged' |
| Root cause | Other |
| Action | 3M sent letter dated 11/05/04 to distributors asking distributors to notify their customers immediately who received this lot number. A sample notification letter was also included to the distributors for instructing the retail location to return product to 3M. |
| Quantity | 147 cases. each case represents 24 rolls. for a total of 3528 rolls |
| Distribution | Product sent to 38 retail healthcare product distributors located throughout the US and guam. States include MN, IL, MO, CO, TX, PA, MA, MD, NJ, NY, GA, NC, SC, WA, CA and Hawaii |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.