Recall Z-0945-2021— Mar-Med Co

Name: FDA recall Z-0945-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-28

Class II · Terminated

Class II FDA medical device recall by Mar-Med Co, initiated 2020-12-28, terminated 2023-09-14. It names one FDA 510(k) clearance: K853472. 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: 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..

Recalling firm: Mar-Med Co
Classification: Class II
Status: Terminated
Initiated: 2020-12-28
Terminated: 2023-09-14
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K853472 — FINGER TOURNIQUETTEJoseph B. Marogil·cleared 1985-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.