FDADecember 28, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
mar medmarmar med
UPCs
00855364004085
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-282026-05-27
- FDAORGANIC IQF CHOPPED SPINACH 35 lbs. Net Weight Product is not ready to eat. For food safety, cook to an internal temperature of 165 degrees F as measured with a food thermometer. PACKED BY DEL MAR FOOD PRODUCTS CORP., WATSONVILLE, CA 95077, U.S.A. UPC: 1822V2025-10-07
- FDABen's Original Ready Rice Long Grain & Wild, 8.8oz., UPC 0 54800 42331 6. 12 retail units per wholesale case2025-09-12
- FDABen's Original Ready Rice Whole Grain Brown, 8.8oz., UPC 0 54800 42334 7. 12 retail units per wholesale case.2025-09-12
- FDABen's Original Ready Rice Original Long Grain White, 8.8oz., UPC 0 54800 42333 0. 12 retail units per wholesale case2025-09-12
- FDADORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)2025-03-14
- FDASUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.2024-11-19
- FDAhuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.2024-10-18
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