Recall Z-1082-2015— Arrow International Inc

Name: FDA recall Z-1082-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-02

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-01-02, terminated 2016-10-25. It names one FDA 510(k) clearance: K071538. Product: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.. Reason: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-02
Terminated: 2016-10-25
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K071538 — ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERArrow International, Inc.·cleared 2007-08-30

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

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

Reason for recall

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

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