Z-1802-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- October 9, 2019
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90
Product Description
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.
Reason for Recall
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Distribution Pattern
US Nationwide distribution including the states of SC, TX, UT, NY, AR
Code Information
Lot Number 10237165