Merit Medical Systems, Inc.: 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

Hazard

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

Details from the source

Reason for recall: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Distribution: 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. Quantity: 432 devices Lot/code info: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877

UPC codes

00884450140840

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.