Recall Z-2348-2015 ยท KCY Tourniquet, Pneumatic
Zimmer Surgical Inc
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.
| Date | Aug 6, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. |
| Root cause | Labeling False and Misleading |
| 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 CorporateQuality.PostMarket@zimmer.com. Customers with questions were instructed to call 330-364-0989. |
| Quantity | 61 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.