Z-0629-2016 Class II Terminated
FDA device recall Z-0629-2016 was initiated by Stryker Sustainability Solutions on Dec 17, 2015 and is designated Class II. Reason for recall: Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. The recall status is terminated (terminated Jul 14, 2016). Affected quantity: 450 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Dec 17, 2015
- Termination Date
- Jul 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 devices
Product 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 for Recall
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Distribution Pattern
Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0629-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026