# FDA recall Z-0945-2021

> **Mar-Med Co** · Class II · device recall initiated 2020-12-28.

## 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.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0945-2021
- **Recalling firm:** Mar-Med Co
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-28
- **Report date:** 2021-02-10
- **Termination date:** 2023-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2021

## Citation

> AI Analytics. FDA recall Z-0945-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0945-2021. Source: US FDA. Licensed CC0.

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