Recall Z-1692-2023 ยท OHM Cesarean Section Tray
DeRoyal Industries Inc
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
| Date | Jun 7, 2023 (initiated Apr 17, 2023) |
| Status | Open, Classified |
| Reason | The custom procedure packs contain light handle covers that have been recalled by another firm. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a letter dated 4/14/2023 to their sole consignee via email on 4/17/2023. The letter explained the reason for recall, the risk associated with the use of the device, and referred the customer to see the attached Affected Products Listing for detailed information, as the spreadsheet indicates the DeRoyal product numbers and lot numbers shipped to the customer. Additionally, the spreadsheet indicates the STERIS reference number, LB53, and lot numbers affected. The letter points out the recall is for the sterile STERIS light handle cover and the rest of the pack is not |
| Quantity | 23 cases (52 packs) |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.