Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Level 1 Fast Flow Fluid Warmer | Not applicable. | H-1129 H-1100 |
| Level 1 NORMOFLO Irrigation Fluid Warmer | Not applicable. | H1100 H-1200-EN-115V |
Issue
Smiths Medical is issuing this letter to notify customers of a potential issue related to the Level 1 Fast Flow Fluid Warmers and Level 1 NORMOFLO Irrigation Fluid Warmers:
1. The return tube assembly inside the warmers may exhibit stress cracking that can propagate over time and potentially result in leaking recirculating fluid. Leaking recirculating fluid may potentially damage other components within the warmer, such as the printed circuit board.
2. The cable inside the warmers that connects to the external on/off switch may potentially exhibit delamination of insulation which may propagate over time and may lead to corrosion and a break in the electrical circuit.
Recall Start Date: July 2, 2024
Additional information
Details
Smiths Medical Asd, Inc.
6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
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