Recall Z-2499-2021 ยท LRO General Surgery Tray
Deroyal Industries, Inc. Lafollette
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
| Date | Sep 29, 2021 (initiated Sep 2, 2021) |
| Status | Terminated |
| Reason | DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal issued their recall on 09/03/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal. |
| Quantity | 2880 units |
| Distribution | US distribution in Florida and South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |