Back to RecallTracker
Health Canada Medical devices

Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer

Issued July 19, 2024
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
Hazard description
Performance
Product
Product name
Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer
Reference
ID
RA-75836