FDA Medical Device Recalls (openFDA)
3m Health Care: 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ
- Recall number
- Z-0839-03
- Recalling firm
- 3m Health Care
- Product
- 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ
- Status
- Terminated
- Initiated
- 2003-04-07
- Posted
- 2003-05-16
- Terminated
- 2004-07-02
- Reason
- The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- Root cause
- Other
- Action
- 3M sent Cardinal Health a letter dated April 7, 2003 to provide to their customers. The letter instructed the customers to remove Ioban 2 drapes contained in Cardinal Health packs and use a separately supplied equivalent drape.
- Quantity
- 4393 drapes
- Distribution
- Procedure packs containing the drapes were shipped nationwide in United States.
- Lot, serial or model codes
- 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 2110898
- Firm city
- Saint 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