3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
FDA device recall Z-0838-03 · posted 2003-05-16 · Terminated
Recall details
- Recalling firm
- 3m Health Care
- Reason for recall
- The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 3679 drapes
- Distribution
- Procedure packs containing the drapes were shipped nationwide in United States.
- Date initiated
- 2003-04-07
- Date posted
- 2003-05-16
- Date terminated
- 2004-07-02
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M GERMICIDAL SURGICAL INCISE DRAPE (K801550) | 3M Company | 1981-09-17 |