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Zimmer Surgical Inc recalls 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to
Recalled August 12, 2015 · FDA recall Z-2349-2015 · Zimmer Surgical
Hazard
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. · FDA Class II
Units
330 units
Sold at
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.
Description
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Product
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Manufacturer(s)
Zimmer Surgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →