FDA-Device2017-05-03Class II

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.

Merit Medical Systems, Inc.
Hazard

Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.

Sold states
Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
Affected count
23,032 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1889-2017

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