Recall Z-1315-2023— Stryker Sustainability Solutions

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2023-03-01. FDA's recall record names no specific 510(k) clearance for this event. 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; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;. Reason: Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications..

Recalling firm

Stryker Sustainability Solutions

Classification

Class II

Status

Ongoing

Initiated

2023-03-01

Firm location

Tempe, AZ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.