FDA-Device2014-10-01Class II
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.
Argon Medical Devices, Inc
Hazard
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Sold states
Nationwide Distribution.
Affected count
3,783 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2696-2014Don't want to check this manually?
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