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: 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.

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.