FDA recall Z-2405-2024

Stryker Sustainability Solutions · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.

Key facts

Status
Ongoing
Initiation date
2024-05-31
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

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