Recall Z-0656-2018— Arrow International Inc

Name: FDA recall Z-0656-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-10-17, terminated 2020-04-14. It names one FDA 510(k) clearance: K993691. Product: ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018. Reason: These finished good kits may contain the incorrect Springwire Guide (SWG)..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2020-04-14
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K993691 — ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.·cleared 2000-03-08

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 Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

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