Recall Z-1832-2021 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
| Date | Jun 10, 2021 (initiated May 14, 2021) |
| Status | Terminated |
| Reason | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by email on May 14, 2021. The notice explained the problem and hazard,. Customers were instructed to complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. and return to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com Customers were asked to PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. Distributors were instructed to notify their customers. |
| Quantity | 12 trays |
| Distribution | US Nationwide distribution to the states of MS, VA, LA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |