Recall Z-1152-2018— Arrow International Inc

Name: FDA recall Z-1152-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-21

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-12-21, terminated 2020-04-20. It names one FDA 510(k) clearance: K993691. Product: ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter 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 ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.. Reason: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Terminated: 2020-04-20
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 catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter 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 ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

Reason for recall

Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

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