Device product
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.
Z-2696-2014
Product summary
- Event
- Event 68521
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,783 units
- Official record key
device-enforcement:Z-2696-2014
Official wording
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Code information: Lot Numbers: 11034387, 11034915, 11039525, 11045439, 11057890, 11059625, 11027376, 11034000, 11035976, 11036453, 11038334, 11041518, 11044383, 11047511, 11049668, 11052111, 11054546, 11059459, 11060050, 11033757, 11041251, 11044868, 11050693, 11054199, 11059627, 11061874, 11067035, 11021364, 11034424, 11059468, 11034914, 11035965.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.