Deroyal Industries, Inc. Lafollette Recall 88660
Description: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Deroyal Industries, Inc. Lafollette Recall 88660 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2499-2021 |
| Event ID | 88660 |
| Event Description | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set |
| Product Type | Devices |
| Distribution | US distribution in Florida and South Carolina. |
| Quantity | 2880 units |
| Recall 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. |
| Device Classification | 20211006 |
| Device Code Info | 1) CYSTO PACK PGYBK / 89-5721.03 Lot 46459298 exp 10/01/2021 Lot 47042849 exp 11/01/2021 Lot 47217717 exp 01/01/2022 Lot 47461066 exp 04/10/2022 Lot 47525103 exp 04/01/2022 Lot 47696113 exp 05/01/2022 Lot 48210787 exp 07/01/2022 Lot 49049665 exp 10/01/2022 Lot 47525103 exp 04/01/2022 Lot 49101769 exp 07/01/2022 Lot 49215918 exp 11/01/2022 Lot 49291064 exp 11/1/2022 Lot 49351178 exp 01/01/2023 Lot 49455989 exp 01/01/2023 Lot 49683631 exp 01/01/2023 Lot 50920251 exp 03/01/2023 Lot 51081699 exp 08/01/2023 Lot 51253374 exp 08/01/2023 Lot 52004222 exp 10/01/2023 Lot 52658453 exp 02/01/2024 Lot 53216841 exp 02/01/2024 Lot 53666480 exp 09/01/2024 Lot 54367035 exp 01/01/2025 2) GU TUR BASIN SET PGYBK / 89-6425.07 Lot 52173376 exp 10/1/2021 Lot 52902866 exp 12/01/2021 Lot 53216518 exp 12/01/2021 Lot 53331541 exp 12/01/2021 Lot 53411946 exp 03/01/2022 Lot 53598712 exp 02/01/2022 Lot 53784881 exp 09/01/2022 Lot 53888656 exp 03/01/2022 Lot 53964621 exp 03/01/2022 Lot 54009801 exp 08/01/2022 Lot 54246494 exp 09/01/2022 |
| Center Classification Date | 20210929 |
| Recall Initiation Date | 20210902 |
| Recalling Firm | Deroyal Industries, Inc. Lafollette |
| Initial Notification | |
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