Reported Oct 23, 2024 · Ongoing
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 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.
- Lot codes and dates
- Catalog NumberIN2430/B
- UDI-DI code00884450298053
- Lot Number
67 of 67 codes
H2298615H2305035H2309343H2320982H2326310H2353508H2369554H2385820H2395793H2398305H2413092H2416388H2421988H2426107H2432428H2435884H2442968H2446110H2453676H2457934H2462756H2466450H2478394H2486953H2492841H2497956H2507120H2517518H2522878H2528487H2540012H2545411H2554635H2568222H2574049H2579554H2584201H2589843H2594941H2599815H2614054H2618904H2622809H2633299H2639296H2645647H2649894H2655507H2660062H2664663H2669780H2673558H2697508H2713941H2733075H2746745H2751196H2765642H2806015H2815182
- Amount recalled
- 6,565 devices
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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