FDA-Device2024-01-10Class II

Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY

Merit Medical Systems, Inc.
Hazard

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Sold states
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
Affected count
59 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0628-2024

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