Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-0486-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 10, 2017

Date Posted: February 21, 2018

Recall Number: Z-0486-2018

Event ID: 78681

Reason for Recall:

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

Status: Terminated

Product Quantity:

Code Information:

Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547

Distribution Pattern:

...

Voluntary or Mandated:

Voluntary: Firm initiated