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.
FDA Recall Z-0264-05 · Posted 2004-11-30
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Recalling Firm3M Company / Medical Division
Recall StatusTerminated
Product CodeFRO
Date Initiated2004-11-05
Date Terminated2005-11-17
Product Quantity147 cases. each case represents 24 rolls. for a total of 3528 rolls
Reason for Recall
Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged'
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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