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

    • 701610001
    • K08-02053A
    • K08-02111A
    • K-08-2192A
    • K08-02385
    • K08-02385P
    • K08-02649
    • K08-02690
    • K08-02930a
    • K08-03044
    • K08T-02829
    • K09-00807AD
    • K09-01467AC
    • K09-01467AD
    • K09-01732N
    • K09-02334N
    • K09-02608A
    • K09-03491HP
    • K09-03586AC
    • K09-03743L
    • K09-04300Q
    • K09-04775HP
    • K09-04916JP
    • K09-05525A
    • K09-05648GP
    • K09-05993F
    • K09-07692D
    • K09-08374C
    • K09-08485F
    • K09-08556G
    • K09-08592N
    • K09-08603B
    • K09-08720G
    • K09-08720H
    • K09-08743L
    • K09-08743M
    • K09-08790C
    • K09-08813J
    • K09-09067C
    • K09-09144B
    • K09-09221CP
    • K09-09280A
    • K09-09326
    • K09-09418CP
    • K09-09439
    • K09-09474H
    • K09-09527D
    • K09-09657AP
    • K09-09672AP
    • K09-09677A
    • K09-09683l
    • K09-09683LP
    • K09-09859FP
    • K09-09966AP
    • K09-09966BP
    • K09-09983A
    • K09-10008C
    • K09-10009D
    • K09-10312
    • K09-10457C
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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 9, 2017 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.