Recall Z-0576-03 ยท KKX Drape, Surgical, Antimicrobial
Allegiance Healthcare Corp.
Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
| Date | Feb 25, 2003 (initiated Jan 22, 2003) |
| Status | Terminated |
| Reason | The product labeled as sterile had not been through its sterilzation cycle. |
| Root cause | Other |
| Action | Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers. |
| Quantity | 320 drapes |
| Distribution | New Jersey, Georgia, Washington and Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002419 | SURGICAL DRAPES Allegiance Healthcare Coporation, Aug 15, 2000 |