FDA-Device2013-06-05Class II
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Merit Medical Systems, Inc.
Hazard
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Sold states
USA Nationwide Distribution.
Affected count
1,465
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2013Don't want to check this manually?
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