Recall Z-2003-2018— Arrow International Inc

Name: FDA recall Z-2003-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-11

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-04-11, terminated 2020-05-15. It names one FDA 510(k) clearance: K993691. Product: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH. Reason: Product sterility may be compromised due to unsealed packaging..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Terminated: 2020-05-15
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

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH

Reason for recall

Product sterility may be compromised due to unsealed packaging.

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