Mar-Med Co recalls Tourni-Cot Universal Tourniquets (Model TCU) due to risk of finger/toe injury if improperly removed. The device may tear and constrict blood vessels, causing tissue damage. Affected units have UDI 00855364004085.
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.
Mar-Med Co is recalling its Tourni-Cot Universal Tourniquet (Model TCU) because improper removal can cause the device to tear and constrict blood vessels, potentially leading to tissue damage in fingers or toes. This risk occurs when users attempt to remove it by snipping the edge and pulling.
The device can tear into two pieces if partially snipped and pulled during removal. This causes one piece to remain in place and constrict blood vessels, potentially leading to tissue damage in fingers or toes.
People who use the Tourni-Cot for finger or toe surgery are most at risk. The recall affects all units sold with UDI 00855364004085.
Check for the model number TCU and universal label on the device. Affected units have the unique device identifier (UDI) 00855364004085.
Look for signs of partial snipping or pulling on the device edge, which may indicate improper removal.
If the device shows signs of tearing or constriction, stop using it immediately to prevent tissue damage.
The device can tear if removed by partially snipping the edge and pulling, which may cause it to constrict blood vessels and lead to tissue damage in fingers or toes.
Check for the model number TCU and universal label on the device. Affected units have the unique device identifier (UDI) 00855364004085.
If the device shows signs of tearing or constriction, stop using it immediately. Check for the UDI 00855364004085 to confirm if it's affected.
We’ve drafted a message you can send Mar-Med Co to request your refund or repair — edit it as you like.
Subject: Recall Z-0945-2021 — Mar-Med Co Mar-Med Co Hello, I own a Mar-Med Co that is covered by recall Z-0945-2021 from Mar-Med Co. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
