Mar-Med Co: Medical Device Recall in 2021 - (Recall #: Z-0945-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 28, 2020

Date Posted: February 10, 2021

Recall Number: Z-0945-2021

Event ID: 87009

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.

Status: Terminated

Product Quantity: 52,000

Code Information:

All lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated