Device product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Z-0045-2014
Product summary
- Event
- Event 66400
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-0045-2014
Official wording
Reason: 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Code information: Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.
Distribution pattern: US Distribution including the states of CO, VA, and MS.
Derived failure modes
-
Unknown
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.