Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis
Recalled Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Hazard / Issue
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Issued by
FDA
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