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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs

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  Class 2 Device Recall Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs see related information
Date Initiated by Firm December 17, 2015
Date Posted January 12, 2016
Recall Status1 Terminated 3 on July 14, 2016
Recall Number Z-0629-2016
Recall Event ID 72880
Product Classification Tourniquet, pneumatic - Product Code KCY
Product Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs

Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236

Indicated for use in patients who require surgery of the extremities.
Code Information Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		 Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm sent out customer notification letters on 12/17/15. The firm requests that customers discontinue the use of the affected lots of the recall product, and other Pressure Tourniquet Cuffs reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to the customer is included with the notification. The firm states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The letter states the form needs to be completed even if no product is found. If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in Commerce 450 devices
Distribution Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
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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