FDA Recall
Terminated
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Recall: Z-2499-2021
·
Initiated September 2, 2021
Recall
- Recall Number
- Z-2499-2021
- Event Number
- 88660
- Firm
- Deroyal Industries, Inc. Lafollette
- FEI Number
- 3005011024
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 2, 2021
- Posted
- September 29, 2021
- Terminated
- December 18, 2023
- Address
- 1501 E Central Ave La, Follette, TN, 37766-2892
Description
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
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.
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.
Distribution
US distribution in Florida and South Carolina.
Quantity
2880 units