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.
Recall
- Recall Number
- Z-2348-2015
- Event Number
- 71575
- Firm
- Zimmer Surgical Inc
- FEI Number
- 1526350
- Product Code
- KCY
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- June 24, 2015
- Posted
- August 6, 2015
- Terminated
- November 4, 2016
- Address
- 200 W Ohio Ave, Dover, OH, 44622-9642
Description
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.
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
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.
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.
61 units