FDA Enforcement
Class II
Terminated
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.
Recall: Z-0629-2016
·
Reported January 20, 2016
Enforcement
- Recall Number
- Z-0629-2016
- Event ID
- 72880
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 20, 2016
- Initiation Date
- December 17, 2015
- Classification Date
- January 12, 2016
- Termination Date
- July 14, 2016
- Address
- 1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States
Description
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.
Reason
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Code Info
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
Distribution
Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
Quantity
450 devices