FDA recall Z-0486-2018

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.

Reason for recall

Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

Distribution

...

Key facts

Status

Terminated

Initiation date

2017-07-10

Report date

2018-02-21

Termination date

2018-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2018