Home › ITL ASIA PACIFIC SDN. BHD. › ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS
ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS
ITL ASIA PACIFIC SDN. BHD. · Model A600001 · UDI-DI 19555240404098
GAX
Prescription
10
510(k) clearances
89
Adverse events (2 deaths)
8
Recalls
338
Facilities
Description
The tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The device is for single patient use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-28 | Mar-Med Co | 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 plac |
| 2018-05-02 | The Seaberg Company Inc | 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 pati |
| 2018-05-02 | The Seaberg Company Inc | 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 pati |
| 2018-05-02 | The Seaberg Company Inc | 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 pati |
| 2015-08-31 | Pyng Medical Corporation | 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 |
| 2014-08-05 | ICU Medical, Inc. | 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 produ |
| 2014-08-05 | ICU Medical, Inc. | 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 produ |
| 2014-08-05 | ICU Medical, Inc. | 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 produ |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.