DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA device recall Z-2499-2021 · posted 2021-09-29 · Terminated
Recall details
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 2880 units
- Distribution
- US distribution in Florida and South Carolina.
- Date initiated
- 2021-09-02
- Date posted
- 2021-09-29
- Date terminated
- 2023-12-18
- Location
- La Follette, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |