Recall Z-1290-2022— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-1290-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-05

Class II · Terminated

Class II FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2022-05-05, terminated 2024-09-04. It names one FDA 510(k) clearance: K970864. Product: Arrow Three-Lumen CVC. Reason: Gravity flow rates on the affected product lidstock are incorrect..

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-05-05
Terminated: 2024-09-04
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K970864 — ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSArrow Intl., Inc.·cleared 1997-10-17

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 Three-Lumen CVC

Reason for recall

Gravity flow rates on the affected product lidstock are incorrect.

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