Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

Plain-English summary

Stryker Sustainability Solutions is recalling 127,894 disposable tourniquet cuffs sold under the Color Cuff brand. The affected products include Single Port and Dual Port models in multiple sizes (18, 30, and 34 millimeters) with Quick Connect connections.

The cuffs are being recalled due to reports of increased incidence of units that cannot achieve or maintain the desired pressure required for surgical procedures. Two defects have been identified: the cuff fabric may tear during use, or the O-ring at the connection between the cuff, fill line, and hosing may become pinched or unseated.

These defects may result in loss of vascular occlusion (cessation of blood flow), potentially leading to operative site blood loss, hemorrhage, and other surgical complications. The affected cuffs have been distributed across all 50 states and the District of Columbia.

Healthcare facilities should immediately stop using the affected lot numbers and contact Stryker Sustainability Solutions regarding replacements or additional guidance.

The recalled product

Product

Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;

Manufacturer

Stryker Sustainability Solutions

Category

Medical Device — Surgical Tourniquet

Hazard

• pressure-loss
• fabric-tearing
• seal-failure
• hemorrhage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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