Medical device recalls Moderate risk

Merit Medical Systems, Inc. recalls 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MS…

Recall date
March 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1889-2017
FDA classification
Class II
Brand / firm
Merit Medical Systems, Inc.
Sold / distributed
Nationwide and other foreign consignees. No VA/govt/military or VA consignees.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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