FDA recall Z-0945-2021

Mar-Med Co · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2020-12-28
Report date
2021-02-10
Termination date
2023-09-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2021