Reported May 3, 2017 · Terminated

1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R,…

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?

  • 1 mL Medallion¿ Syringe
  • Catalog Numbers
    • 701989001
    • K01-05197P
    • MSS011-YP
    • K01-07946P
    • MSS011
    • MSS011-LB
    • MSS011-R
    • MSS011-Y
    • MSS011P
    • MSS011-LBP
    • MSS011-DG
    • K08-02926AP
    • K01-07742P
    • K10-05457P
Lot codes and dates
  • Lot Numbers
    • B617173
    • H1082598
    • H1082648
    • H1082649
    • H1082809
    • H1085511
    • H1085645
    • H1092907
    • H1085649
    • H1097018
    • H1085658
    • H1085659
    • H1085735
    • H1089234
    • H1089419
    • H1090184
    • H1101188
    • H1101443
Amount recalled
23,032 units

Where it was sold

  • Nationwide
  • VA

Why it was recalled

Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a 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 Sep 26, 2017 · Data as of Sep 19, 6:04 PM UTC

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