GM-30 Accessory Kit
Nipro Vascular Innovations Americas, Inc. · Model GLGMN-YOK0A · UDI-DI 04543660023508
Description
This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device. OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A) The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N) Indications for Use: 1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. 2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-04 | Merit Medical Systems, Inc. | Inflation device handle may detach from the syringe during procedure. |
| 2025-08-05 | Boston Scientific Corporation | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2021-06-10 | Merit Medical Systems, Inc. | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. |
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