Recall Z-2349-2015
Zimmer Surgical Inc · initiated June 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.
Reason for recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
FDA-determined 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.
Details
- Recall number
- Z-2349-2015
- Initiated
- June 24, 2015
- Posted by FDA
- August 6, 2015
- Terminated
- November 4, 2016
- Product code
- KCY – Tourniquet, Pneumatic
- Quantity
- 330 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.
- Recalling firm
- Zimmer Surgical Inc, Dover, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2348-2015 Class II | 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc.…The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. | 06/24/2015Terminated |