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Stryker Sustainability Solutions recalls Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 59
Recalled January 20, 2016 · FDA recall Z-0629-2016 · Stryker Sustainability Solutions
Hazard
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. · FDA Class II
Units
450 devices
Sold at
Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
Description
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Product
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →