Color Cuff - Sterile Disposable Tourniquet Cuffs
Last updated
Summary
Product
Color Cuff - Sterile Disposable Tourniquet Cuffs
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Color Cuff - Sterile Disposable Tourniquet Cuffs | More than 10 numbers, contact manufacturer. | 5921-018-235 |
| Color Cuff - Sterile Disposable Tourniquet Cuffs | More than 10 numbers, contact manufacturer. | 5921-018-135 |
| Color Cuff - Sterile Disposable Tourniquet Cuffs | More than 10 numbers, contact manufacturer. | 5921-024-235 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Stryker Instruments, A Division Of Stryker Corporation
1941 Stryker Way, Portage, Michigan, United States, 49002
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77715
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