FDA-Device2014-10-01Class II
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (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 Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (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-2698-2014Don't want to check this manually?
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