Device product
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Z-0162-2015
Product summary
- Event
- Event 69452
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0162-2015
Official wording
Reason: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Code information: Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014
Distribution pattern: Nationwide and to India. No govt/military/VA consignees.
Derived failure modes
-
Unknown
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.