FDA recall Z-1802-2020

Stryker Sustainability Solutions · Class II · 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.

Reason for recall

Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Distribution

US Nationwide distribution including the states of SC, TX, UT, NY, AR

Key facts

Status
Terminated
Initiation date
2019-10-09
Report date
2020-05-06
Termination date
2021-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1802-2020