Z-2349-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2015
- Initiation Date
- June 24, 2015
- Termination Date
- November 4, 2016
- Voluntary/Mandated
- N/A
- Product Quantity
- 330 units
Product Description
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.
Reason for Recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
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.
Code Information
Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.