Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product...
FDA Recall #Z-0945-2021 — Class II — December 28, 2020
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.
Recalling Firm
Mar-Med Co — Grand Rapids, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
52,000
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.
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated