Device product
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.
Z-1408-2013
Product summary
- Event
- Event 65150
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,465
- Official record key
device-enforcement:Z-1408-2013
Official wording
Reason: Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Code information: Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391
Distribution pattern: USA Nationwide Distribution.
Derived failure modes
-
Unknown
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.