Recall Z-1833-2021 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
| 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 | 66 packs |
| 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
This recall record lists no 510(k) number.