Recall Z-0575-2023 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
| Date | Dec 15, 2022 (initiated Nov 3, 2022) |
| Status | Open, Classified |
| Reason | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued an URGENT RECALL NOTICE to its consignees on 11/03/2022 by email and US mail. 1) Using the attached Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. 2) DeRoyal will contact you to schedule time to affix labels to all affected product. These labels indicate that, at the time of use, the affected product should be removed from the kit/tray and destroyed. These products should be destroyed according to your facility, local, state and federal regulations. 3) DeRoyal representative will de |
| Quantity | 42 kits |
| Distribution | US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.