Public recall detail

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

2024-07-19

medium
Recall Safety notice
Quick summary

Quick summary: Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer. Date: 2024-07-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer. Date: 2024-07-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSmiths Medical Asd Inc.
ProductLevel 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75836

Affected products

ProductLevel 1 Fast Flow Fluid Warmer
LotNot applicable.
ModelH-1129 H-1100
Serial numberNot applicable.
DescriptionLevel 1 Fast Flow Fluid Warmer
ProductLevel 1 NORMOFLO Irrigation Fluid Warmer
LotNot applicable.
ModelH1100 H-1200-EN-115V
Serial numberNot applicable.
DescriptionLevel 1 NORMOFLO Irrigation Fluid Warmer

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75836
Background{}
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
AudiencesHealthcare
Source updated2024-07-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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