Reported Jun 21, 2023 · Ongoing
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
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?
- Aspira Valve Repair Kit
- REF4992306 Version A, Sterile EO, Rx Only
- Lot codes and dates
Lot # I2604364I2604393I2587036I2564649I2558681I2604394I2609065I2623156I2577984
- UDI-DI00884450394960
- Amount recalled
- 2559 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
There is a potential that valve assemblies will not open. preventing fluid from draining.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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