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.
FDA Recall Z-2349-2015 · Posted 2015-08-06
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Recalling FirmZimmer Surgical Inc
Recall StatusTerminated
Product CodeKCY
Date Initiated2015-06-24
Date Terminated2016-11-04
Product Quantity330 units
Reason for Recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Firm Action
Zimmer sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, identify the affected product and replace the IFU with the enclosed corrected IFU.
Customers were also instructed to complete the attached Response Form and return it via email to [email protected]. Customers with questions were instructed to call 330-364-0989.
Root Cause
Labeling False and Misleading
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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