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Level 1 H-2 Pressure Chamber — recall 64354

Health Canada — Medical Devices · Canada · 2022-07-11 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
64354
Date of alert
2022-07-11
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: Smiths Medical implemented a design change in 2016 to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. Smiths Medical has become aware that Level 1 H-2 Pressure Chambers with the wider hinge assembly can potentially impact the amount of pressure exerted onto the IV fluid bag while contained within the pressure chamber. This may result in decreased flow rate, stopped flow or residual fluid left within the IV bag. Pressure chambers with the wide hinge assembly are more susceptible to this issue in the following scenarios: 1) kinked tubing on the disposable administration sets. 2) use of the lowest flow rate disposables (DI-50, D-70 or DI-70) when delivering viscous fluids such as chilled blood from 300 mL or smaller IV bags. Recall start date: July 28, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/level-1-h-2-pressure-chamber

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