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Recall Observatory FDA recall evidence

Device product

18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, 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.

Z-2348-2015

June 24, 2015

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 71575
Status
Terminated
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-2348-2015

Official wording

Reason: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Code information: Item 60707000300, Lot Z000002044

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.