Mar-Med Tourni-Cot Universal Non-Pneumatic Tourniquet Recalled for Tearing Risk
Mar-Med Co is recalling 52,000 Tourni-Cot Universal non-pneumatic tourniquets because they may tear during removal, leaving a portion in place that can constrict blood vessels and cause digit ischemia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where a specific injury (digit ischemia) is described as a potential outcome of a mechanical failure, but no reported injuries or illnesses are stated in the source text.
Plain-English summary
Mar-Med Co is recalling 52,000 units of the Tourni-Cot Universal non-pneumatic tourniquet (Model Number TCU, UDI 00855364004085). The device is intended to be used in surgery on fingers or toes to provide a bloodless field. The recall covers all lots of the product.
The recall is being issued because a failure can occur if a user attempts to remove the device by partially snipping the edge and pulling on it. In such cases, the device may tear into two pieces, with a portion remaining in place. This remaining portion can continue to constrict the vessels, which can result in digit ischemia.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, France, Germany, Greece, Italy, Japan, the Netherlands, Singapore, Spain, Sweden, Switzerland, and the United Kingdom. Users should stop using the device and contact Mar-Med Co for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Mar-Med Co
- Hazard
- Affected units
- 52,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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