ClearanceBrief
Recall Z-2697-2014 ยท MSD Catheter, Hemodialysis, Implanted

Argon Medical Devices, Inc

UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.

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