Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60
FDA device recall Z-1492-04 · posted 2004-09-29 · Terminated
Recall details
- Recalling firm
- Deroyal Surgical -Rose Hill
- Reason for recall
- Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 19 cases
- Distribution
- Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
- Date initiated
- 2004-09-09
- Date posted
- 2004-09-29
- Date terminated
- 2005-05-16
- Location
- Rose Hill, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEROYAL DRAPES, STERILE, NON-STERILE (K030365) | Deroyal Industries, Inc. | 2003-04-29 |