PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 21, 2018 Initiated: July 10, 2017 #Z-0486-2018

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.

Reason for Recall

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

Details

Recalling Firm
Arrow International Inc
Distribution
...
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Arrow International Inc.
Why was this product recalled?
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0486-2018.