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
FDA device recall Z-0264-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- 3M Company / Medical Division
- Reason for recall
- Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged'
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 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
- Date initiated
- 2004-11-05
- Date posted
- 2004-11-30
- Date terminated
- 2005-11-17
- Location
- South St Paul, MN
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