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.
Reported: February 10, 2021 Initiated: December 28, 2020 #Z-0945-2021
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.
Details
- Recalling Firm
- Mar-Med Co
- Units Affected
- 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.
- Location
- Grand Rapids, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mar-Med Co. Units affected: 52,000.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0945-2021.
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