Device product
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Z-0486-2018
Product summary
- Event
- Event 78681
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0486-2018
Official wording
Reason: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Code information: Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547
Distribution pattern: ...
Derived failure modes
-
Foreign material or chemical contamination
foreign matter