Recall Z-0838-03 ยท KKX Drape, Surgical, Antimicrobial
3m Health Care
3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
| Date | May 16, 2003 (initiated Apr 7, 2003) |
| Status | Terminated |
| 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 | 3679 drapes |
| Distribution | Procedure packs containing the drapes were shipped nationwide in United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801550 | 3M GERMICIDAL SURGICAL INCISE DRAPE 3M Company, Sep 17, 1981 |