Recall Z-0003-2024— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-0003-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-10

Class I · Ongoing

Class I FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2023-08-10. It names one FDA 510(k) clearance: K071538. Product: Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days. Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits..

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-08-10
Firm location: Morrisville, NC, 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

Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Reason for recall

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

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