Reported Jan 10, 2024 · Ongoing
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, 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?
- Fountain
- REFIS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
- Lot codes and dates
- REFIS4-135-30 Lot #
- H2765720 UDI00884450000885
- REFIS4-90-10 Lot #
- H2765603 UDI00884450006504
- Amount recalled
- 3 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The sterility of microcatheter and infusion system devices cannot be guaranteed.
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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