ClearanceBrief
Recall Z-2696-2014 ยท MSD Catheter, Hemodialysis, Implanted

Argon Medical Devices, Inc

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.

DateSep 24, 2014 (initiated Jun 5, 2014)
StatusTerminated
ReasonUltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Root causeComponent design/selection
Quantity3,783 units
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K023847HEMO-STREAM HEMODIALYSIS CATHETER SET
Rex Medical, Apr 30, 2003
K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
Rex Medical, Nov 18, 2010