Reported Nov 30, 2016 · Terminated
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a…
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?
- Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
- Lot codes and dates
- Part Number
143 of 143 codes
701610001K08-02053AK08-02111AK-08-2192AK08-02385K08-02385PK08-02649K08-02690K08-02930aK08-03044K08T-02829K09-00807ADK09-01467ACK09-01467ADK09-01732NK09-02334NK09-02608AK09-03491HPK09-03586ACK09-03743LK09-04300QK09-04775HPK09-04916JPK09-05525AK09-05648GPK09-05993FK09-07692DK09-08374CK09-08485FK09-08556GK09-08592NK09-08603BK09-08720GK09-08720HK09-08743LK09-08743MK09-08790CK09-08813JK09-09067CK09-09144BK09-09221CPK09-09280AK09-09326K09-09418CPK09-09439K09-09474HK09-09527DK09-09657APK09-09672APK09-09677AK09-09683lK09-09683LPK09-09859FPK09-09966APK09-09966BPK09-09983AK09-10008CK09-10009DK09-10312K09-10457C
- Part Number
- Amount recalled
- 107,341 total devices
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
This product could cause temporary or reversible health problems — stop using it.
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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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