Tourniquet, Nonpneumatic
General, Plastic Surgery · 21 CFR 878.5900
Recent MDR events
89 adverse event reports on file
- TOURNEQUETJan 28, 2026InjuryUnkMW5182970
- TOURNI-COT - SMALLJan 2, 2026InjuryMar-med Inc.1832653-2026-00001
- TOURNIQUET, BLOOD COLLECTIONJul 17, 2025InjuryGolden Season Pte LtdMW5172870
- NOVAPLUS ESMARK V1861 6X9 20/CSMar 17, 2025MalfunctionHartmann Usa Inc.21617920
- TOURNIQUET, BLOOD COLLECTIONJan 2, 2025InjuryGold Coast Medical Supply, Lp.MW5164232
- CARESFIELD TOURNIQUETDec 3, 2024MalfunctionCaresfield LlcMW5163108
- LF ESMARK BANDAGE 3X12'Sep 19, 2024MalfunctionHartmann Usa Inc.20255738
- BD VACUTAINER® STRETCH LATEX FREE TOURNIQUETAug 30, 2024MalfunctionBecton Dickinson2243072-2024-00942
- RADISTOP RADIAL COMPRESSIONMay 3, 2024InjurySt. Jude Medical Puerto Rico, Inc.2648612-2024-00001
- TOURNIQUET, ORANGE, 1"X18", FLATOct 31, 2023InjuryMedline Industries, Lp1417592-2023-00432
Event type breakdown
Recalls
8 recall events for this product code
- Mar-Med CoTerminatedFeb 2, 2021
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers
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.
Z-0945-2021 · View FDA record ↗ - ICU Medical, Inc.TerminatedAug 20, 2014
CAP Change Kit w/MicroClave Clear, Item No. B78109
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Z-2293-2014 · View FDA record ↗ - ICU Medical, Inc.TerminatedAug 20, 2014
Cap Change Kit with MicroClave Clear Connector, Item No. B79103
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Z-2294-2014 · View FDA record ↗ - ICU Medical, Inc.TerminatedAug 20, 2014
Port Access Kit with MicroClave Clear Connector, Item No. B79104
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Z-2295-2014 · View FDA record ↗ - Pyng Medical CorporationTerminatedUnknown
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008;
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
Z-0228-2016 · View FDA record ↗ - The Seaberg Company IncTerminatedUnknown
Part #: SAM XT-M, Model: Tactical Black or Military
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Z-2226-2018 · View FDA record ↗ - The Seaberg Company IncTerminatedUnknown
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Z-2227-2018 · View FDA record ↗ - The Seaberg Company IncTerminatedUnknown
Part #: SAM XT-C, Model: Hi-Viz Blue
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Z-2228-2018 · View FDA record ↗
Registered firms
341 firms currently registered for this product code
Anping Guardian Medical Equipment Co.,ltd
Hengshui Hebei, CN
Bio Nuclear Diagnostics, Inc.
TORONTO Ontario, CA
Nanjing J Sun Healthcare Co.,ltd
Nanjing Jiangsu, CN
M2 Inc.
Camp Johnson, VT, US
Guangdong Comfort Medical Products Co., Ltd.
Jiangmen Guangdong, CN
Wenzhou Shengkai Technology Industry Co.,ltd
Wenzhou city Zhejiang, CN
Quality Latex Products (pvt) Ltd
hanwella Western, LK
Medstar Healthcare Co.,limited
Huzhou Zhejiang, CN
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Normed
SEATTLE, WA, US
Tuper Medical Co., Ltd.
Dezhou City Shandong, CN
Snakestaff Systems
South Salt Lake, UT, US
Harsoria Healthcare Pvt. Ltd. (unit-2)
Baddi Himachal Pradesh, IN
Trademark Plastics Inc.
Riverside, CA, US
Anji Hengfeng Sanitary Material Co., Ltd.
Anji Zhejiang, CN
Little Rapids Corporation
GREEN BAY, WI, US
Fidia Pharma Usa Inc.
Florham Park, NJ, US
American Diagnostic Corp.
HAUPPAUGE, NY, US
H&k International Trade Limited (china)
jinhua Zhejiang, CN
Tactical Stitch
Sialkot Punjab, PK
Dongguan City Risen Medical Products Co., Ltd
Dongguan Guangdong, CN
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.
Chengdu Sichuan, CN
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
510(k) clearances
20 clearances for this product code
- Icat SystemsSep 1, 1993
K931198 · UNIQUET
- Barretta Products, Research and Development, Inc.Apr 29, 1988
K881398 · TOURNIQUET
- Spectrum/Hydro-Med Products, Inc.Apr 11, 1988
K881176 · STERILE ESMARCH BANDAGE
- Degania Silicone , Ltd.Jan 7, 1988
K875092 · DEGANIA SILICONE TOURNIQUET
- Dryden Corp.Oct 23, 1987
K873928 · UNIVERSAL TOURNIQUET
- The Kinder Co.Jun 23, 1987
K872003 · KINDERWRAP
- Dale Medical Products, Inc.Jan 12, 1987
K864897 · DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
- Joseph B. MarogilOct 10, 1985
K853472 · FINGER TOURNIQUETTE