Reported Feb 10, 2021 · Terminated
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is…
Mar-Med Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mar-Med Co · 333 Fuller Ave Ne · Grand Rapids, MI · 49503-3630
Is this the product you have?
- Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic
- Tourniquet - Product UsageThe device is intended to be used in surgery on fingers or toes to provide a blood-less field
- Lot codes and dates
- All lots
- Amount recalled
- 52,000
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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