DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Enforcement
- Recall Number
- Z-2499-2021
- Event ID
- 88660
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Deroyal Industries, Inc. Lafollette
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 6, 2021
- Initiation Date
- September 2, 2021
- Classification Date
- September 29, 2021
- Termination Date
- December 18, 2023
- Address
- 1501 E Central Ave, N/A, La Follette, TN, 37766-2892, United States
Description
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
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.
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
US distribution in Florida and South Carolina.
2880 units