Recall Z-0927-2023 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
| Date | Jan 9, 2023 (initiated Dec 12, 2022) |
| Status | Terminated |
| Reason | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach. |
| Root cause | Packaging change control |
| Action | DeRoyal sent an urgent recall notice to its consignees on 12/12/2022 by email and they followed with a letter sent overnight to the end user. The notice explained the problem and the hazard, and requested the following actions be taken: "1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in |
| Quantity | 157 packs |
| Distribution | US Nationwide distribution in the states of IL, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |