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Stryker Sustainability Solutions recalls Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port,
Recalled April 5, 2023 · FDA recall Z-1315-2023 · Stryker Sustainability Solutions
Hazard
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. · FDA Class II
Units
127,894
Sold at
US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT
Description
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.
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;
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →