Device product
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
Z-1802-2020
Product summary
- Event
- Event 85330
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90
- Official record key
device-enforcement:Z-1802-2020
Official wording
Reason: Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Code information: Lot Number 10237165
Distribution pattern: US Nationwide distribution including the states of SC, TX, UT, NY, AR
Derived failure modes
-
Labeling or packaging
mislabeled