Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-

FDA device recall Z-0629-2016 · posted 2016-01-12 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KCY

Quantity affected

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.

Date initiated

2015-12-17

Date posted

2016-01-12

Date terminated

2016-07-14

Location

Tempe, AZ