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U.S. Department of Health and Human Services

Class 2 Device Recall Nexcare HoldFast Roll Gauze

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 Class 2 Device Recall Nexcare HoldFast Roll Gauzesee related information
Date Initiated by FirmNovember 05, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on November 17, 2005
Recall NumberZ-0264-05
Recall Event ID 30407
Product Classification Dressing, Wound, Drug - Product Code FRO
Product3M 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.
Code Information Lot # 4267. Catalog number HF-2R
Recalling Firm/
Manufacturer		 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul MN 55411
For Additional Information ContactMatthew Shonk
651-575 Ext. 6171
Manufacturer Reason
for Recall		Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged'
FDA Determined
Cause 2		Other
Action3M 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 in Commerce147 cases. each case represents 24 rolls. for a total of 3528 rolls
DistributionProduct 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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