FDA Device recall Z-0629-2016
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-2…
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-2… by Stryker Sustainability Solutions, citing reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0629-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-17 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
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.
Reason
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Identifiers
| code_info | Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0629-2016%22
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