FDAFDA · Food and drugs·Recall number Z-2697-2014
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.
Published October 1, 2014 · Recall initiated: June 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- Nationwide Distribution.
- Lot
- Lot Numbers: 11029949, 11031335, 11033533, 11035161, 11036607, 11037817, 11039719, 11040058, 11042305, 11044092, 11046743, 11048076, 11049066, 11056427, 11059461, 11024109, 11025359, 11027376, 11028490, 11029950, 11031336, 11034141, 11036893, 11037742, 11038551, 11039237, 11039524, 11039864, 11042306, 11044337, 11048077, 11048786, 11050038, 11054478, 11057548, 11057763, 11059464, 11028491, 11032828, 11034343, 11038165, 11040263, 11042555, 11043587, 11044382, 11047358, 11048923, 11050289, 11054889, 11059622, 11065827, 11035772, 11037651, 11040943, 11059624, 11035771, 11041993, 11050454, 11059467.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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