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Health Canada Medical devices

Color Cuff - Sterile Disposable Tourniquet Cuffs

Issued July 9, 2025
Issue
There is potential for the tourniquet cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain air pressure. On February 12, 2025, a nonconformance was opened to address a manufacturing nonconformance identified through a Stryker complaint investigation for the tourniquet cuff flange becoming detached from the bladder. Less noticeable detached flanges have been reported and events confirmed. Recall start date: June 27, 2025
Hazard description
Performance
Product
Product name
Color Cuff - Sterile Disposable Tourniquet Cuffs
Reference
ID
RA-77715