Device product
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Z-0664-2022
Product summary
- Event
- Event 89535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-0664-2022
Official wording
Reason: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Code information: Lot # 12983349
Distribution pattern: US: KS OK TX OUS: None
Derived failure modes
-
Labeling or packaging
Mislabeling