Z-0945-2021Class II

Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet -

Name: Z-0945-2021 Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet -
Creator: Mar-Med Co
Published: 2020-12-28
License: https://open.fda.gov/license/

MAR-MED Inc. / initiated 2020-12-28 / Terminated / root cause: design

FDA source

Mar-Med Co began a recall of Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers... on 2020-12-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0945-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-28
Posted: 2021-02-02
Terminated: 2023-09-14
Recalling firm: MAR-MED Inc.
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.
Product code: GAX Tourniquet, Nonpneumatic
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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].
Quantity in commerce: 52,000
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 codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0945-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0945-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-02

Product code GAX

K853472Class IFinger TourniquetteJoseph B. Marogil / cleared 1985-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)