FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0264-05
- Recalling firm
- 3M Company / Medical Division
- Product
- 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.
- Status
- Terminated
- Initiated
- 2004-11-05
- Posted
- 2004-11-30
- Terminated
- 2005-11-17
- 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
- Lot, serial or model codes
- Lot # 4267. Catalog number HF-2R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 2110898
- Firm city
- South St Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28