Recall MonitorHealth Products
Color Cuff - Sterile Disposable Tourniquet Cuffs
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Color Cuff - Sterile Disposable Tourniquet Cuffs
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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