Recall Z-0486-2018— Arrow International Inc

Name: FDA recall Z-0486-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-10

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-07-10, terminated 2018-09-14. It names one FDA 510(k) clearance: K810675. 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: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-10
Terminated: 2018-09-14
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K810675 — ARROW RADIAL ARTERY CATHETERIZATION SETArrow Intl., Inc.·cleared 1981-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.