medical Class II Updated 2024-10-23

Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syr

Recalled Product

Melrose Wakefield Hospital REF K05T-2159 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

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877
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