FDA-Device2022-03-02Class II
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Stryker Sustainability Solutions
Hazard
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Sold states
US: KS OK TX OUS: None
Affected count
40 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2022Don't want to check this manually?
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