Recall Z-2696-2014— Argon Medical Devices, Inc

Name: FDA recall Z-2696-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-05

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2014-06-05, terminated 2015-04-08. It names 2 FDA 510(k) clearances: K102043, K023847. Product: UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.. Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Terminated: 2015-04-08
Firm location: Athens, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K102043 — ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERRex Medical·cleared 2010-11-18
K023847 — HEMO-STREAM HEMODIALYSIS CATHETER SETRex Medical·cleared 2003-04-30

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

UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

Reason for recall

UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

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