Recall Z-1490-04 ยท KKX Drape, Surgical, Antimicrobial
Deroyal Surgical -Rose Hill
Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
| Date | Sep 29, 2004 (initiated Sep 9, 2004) |
| Status | Terminated |
| Reason | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Root cause | Other |
| Action | The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04. |
| Quantity | 1971 cases |
| Distribution | Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE Deroyal Industries, Inc., Apr 29, 2003 |