Reported Aug 22, 2018 · Terminated

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

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?

  • 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Lot codes and dates
  • Catalog NumberLot
  • Number
    • K01-05526P H1258821
    • K01-07427 H1263015
    • K01-07477P H1250809 and H1242962
    • K01-07930P H1246733
    • MSS011-DG H1246809
    • K02-00565C H1258361
    • MSS011-LG H1246810
    • K02-01260B H1258575 and H1265248
    • MSS011-PR H1242752
    • MSS011-R H1242754 and H1255507
    • K02-01331A H1252652
    • K04-00748 H1258488 and H1264381
    • MSS011-Y H1246811
    • MSS011-YP H1242927
    • K12-03636 H1258530
    • and MSS011 H1242750
    • H1246807 and H1255504
Amount recalled
22,234

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Supplier manufacturing defect with the syringe plunger tip.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 30, 2020 · Data as of Sep 19, 6:54 PM UTC

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