Reported Oct 23, 2024 · Ongoing
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230…
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 MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 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 NumberIN2230/B
- UDI-DI code00884450298039
- Lot Number
82 of 82 codes
H2287420H2292343H2298614H2305033H2309342H2312490H2320981H2326309H2331538H2337132H2343845H2348707H2353507H2360151H2379871H2385818H2395792H2398304H2413090H2416387H2421986H2432426H2435878H2442961H2446109H2453675H2457933H2458274H2466447H2474177H2478393H2483314H2486956H2492840H2497955H2503844H2507119H2511930H2517517H2522877H2528486H2540011H2545410H2550516H2554634H2560206H2564557H2568221H2574048H2579553H2584200H2589842H2594940H2599814H2604238H2610524H2614052H2618903H2622808H2629605
- Amount recalled
- 41,411 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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