Home / Recalls / Mar-Med Co / Z-0945-2021

Z-0945-2021 Class II Terminated

Recalled by Mar-Med Co — Grand Rapids, MI

Recall Details

Product Type: Devices
Report Date: February 10, 2021
Initiation Date: December 28, 2020
Termination Date: September 14, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 52,000

Product Description

Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

Reason for Recall

A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Singapore, Spain, Sweden, Switzerland, and United Kingdom.

Code Information

All lots