FDA recall Z-0664-2022
Stryker Sustainability Solutions · Class II · device
Product
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Reason for recall
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Distribution
US: KS OK TX OUS: None
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-21
- Report date
- 2022-03-02
- Termination date
- 2025-02-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tempe, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2022