Device product
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Z-2405-2024
Product summary
- Event
- Event 94824
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-2405-2024
Official wording
Reason: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Code information: Lot: 0000564862/ UDI: 00885825015411
Distribution pattern: US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
Derived failure modes
-
Labeling or packaging
Mislabeling