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.
This recall has been terminated (originally issued August 6, 2015).
- Company
- Zimmer Surgical Inc
- Recall Initiated
- June 24, 2015
- Posted
- August 6, 2015
- Terminated
- November 4, 2016
- Recall Number
- Z-2349-2015
- Quantity
- 330 units
- Firm Location
- Dover, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Distribution
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.
Lot / Code Info
Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.
Root Cause
Labeling False and Misleading
Action Taken
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 CorporateQuality.PostMarket@zimmer.com. Customers with questions were instructed to call 330-364-0989.