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Level 1 h-2 pressure chamber
Official notice
11 Jul 2022
Last checked
11 Jul 2022
An official Health Canada notice concerns Level 1 h-2 pressure chamber. 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 Published 2022-07-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64354
Official notice
2022-07-11
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Smiths Medical Asd, Level 1 H-2 Pressure Chamber.
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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