Recall Z-1826-2023— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-1826-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class I · Ongoing

Class I FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2023-05-19. It names one FDA 510(k) clearance: K163513. Product: ARROW Endurance Extended Dwell Peripheral Catheter System. Reason: Potential for catheter separation or leakage.

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-05-19
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K163513 — Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.)·cleared 2017-02-24

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 Endurance Extended Dwell Peripheral Catheter System

Reason for recall

Potential for catheter separation or leakage

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