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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 14, 2023 · Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.