Zimmer Tourniquet Cuff 30 recalled over labeling errors

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Sustainability Solutions recalls Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reproc…

Recall number

Z-1802-2020

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.