PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 1, 2014 Initiated: June 5, 2014 #Z-2696-2014

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.

Details

Units Affected
3,783 units
Distribution
Nationwide Distribution.
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Argon Medical Devices, Inc. Units affected: 3,783 units.
Why was this product recalled?
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 1, 2014. Severity: Moderate. Recall number: Z-2696-2014.