Recall Z-1315-2023 — 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 Du
U.S. FDA — Device Enforcement · United States · 2023-03-01 · Class II
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Reported risk: 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.
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