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U.S. Department of Health and Human Services

Class 2 Device Recall Dual Port/Single Bladder Disposable Tourniquet Cuff

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  Class 2 Device Recall Dual Port/Single Bladder Disposable Tourniquet Cuff see related information
Date Initiated by Firm June 24, 2015
Date Posted August 06, 2015
Recall Status1 Terminated 3 on November 04, 2016
Recall Number Z-2349-2015
Recall Event ID 71575
Product Classification Tourniquet, pneumatic - Product Code KCY
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.
Code Information Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.
Recalling Firm/
Manufacturer		 Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact Customer Service
330-364-0989
Manufacturer Reason
for Recall		 The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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