Health product recall

Level 1 H-2 Pressure Chamber

Last updated

Summary

Product
Level 1 H-2 Pressure Chamber
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Level 1 H-2 Pressure Chamber

More than 10 numbers, contact manufacturer.

7204012

Issue

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

 

Additional information

Details
Original published date: 2022-07-15
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Smiths Medical Asd, Inc.

6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64354