FDA-Device2013-10-30Class II

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

Merit Medical Systems, Inc.
Hazard

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

Sold states
US Distribution including the states of CO, VA, and MS.
Affected count
200
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2014

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