Recall Z-1879-2017— Arrow International Inc

Name: FDA recall Z-1879-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-03-17, terminated 2020-03-24. It names one FDA 510(k) clearance: K071538. Product: Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied. Reason: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Terminated: 2020-03-24
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

Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied

Reason for recall

Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.

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