FDA Medical Device Recalls (openFDA)
3M Company / Medical Division: 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.
- Recall number
- Z-1234-06
- Recalling firm
- 3M Company / Medical Division
- Product
- 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.
- Status
- Terminated
- Initiated
- 2006-02-09
- Posted
- 2006-07-13
- Terminated
- 2007-01-05
- Reason
- After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.
- Root cause
- Other
- Action
- All product in house and at the distributors was put on hold at the time of discovery. Distributors were contacted by telephone between 2/7/06 & 2/8/06 and asked to hold product from affected lots. Recall Letters to distributors dated 2/9/06 were faxed and mailed via UPS next day air on 2/9/06.
- Quantity
- 432 boxes
- Distribution
- Nationwide, with distributors in CA, LA, MI, NJ, OH.
- Lot, serial or model codes
- Lots 6018, 6019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRL
- 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