FDA recall Z-2742-2018

Merit Medical Systems, Inc. · Class II · device

Product

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

Reason for recall

Supplier manufacturing defect with the syringe plunger tip.

Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.

Key facts

Status
Terminated
Initiation date
2018-02-02
Report date
2018-08-22
Termination date
2020-11-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2742-2018