FDA-Device2024-07-24Class II

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Stryker Sustainability Solutions
Hazard

Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

Sold states
US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
Affected count
90 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2024

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