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Recall Observatory FDA recall evidence

Device 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.

Z-0062-2025

August 30, 2024

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 95330
Status
Ongoing
Classification
Class II
Quantity
432 devices
Official record key
device-enforcement:Z-0062-2025

Official wording

Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Code information: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877

Distribution pattern: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.