Tourni-Cot - Universal, UDI 00855364004085, Model Number… recallZ-0945-2021 · Mar-Med Co · initiated Dec 28, 2020
Class II Terminated All recalls posted in February 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mar-Med Co or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
On December 28, 2020, the firm began notifying customers of the recall via Urgent Medical Device Correction letters. Customers were informed that serious injury could occur due to the failure mode associated with the correction. Actions to be taken by the Customer: Ensure proper removal of the Uni-Cot device by completely severing it from the digit, followed by verification that none of the device is remaining. Actions being taken by Mar-Med: Phase 1: Include a notice in each box of the device that identifies the risk for the users of this type of failure and provides specific guidance on how to avoid it. Phase 2: Include a warning tag on the device. The warning tag will not release unless the device is completely removed from the digit. Phase 3: In the near future an update will be made to the design of the device to better address usability and removal, maintaining the inclusion of the warning tag. An updated IFU will also be designed to provide clearer instructions and warnings. Please contact Mar-Med with any questions or information about this type of failure at 616-454-3000 or at [email protected].
Recall details
- Recall number
- Z-0945-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 28, 2020
- Posted by the FDA
- Feb 2, 2021
- Recalling firm
- Mar-Med Co
- Quantity
- 52,000
- Product code
- GAX
- FDA submissions
- K853472
- 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.
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.
Code information (models, lots, serial numbers)
All lots
Other devices under the same FDA submission
2 devices cleared under K853472 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tourni-Cot - Small TCSMar-Med Inc. · Tourniquet, Nonpneumatic1 report
- Tourni-Cot - Universal TCUMar-Med Inc. · Tourniquet, Nonpneumatic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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