Recall Z-0664-2022— Stryker Sustainability Solutions

Name: FDA recall Z-0664-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-21

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2022-01-21, terminated 2025-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder. Reason: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2022-01-21
Terminated: 2025-02-26
Firm location: Tempe, AZ, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.