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Recall Observatory FDA recall evidence

Device product

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.

Z-2697-2014

June 05, 2014

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 68521
Status
Terminated
Classification
Class II
Quantity
3,783 units
Official record key
device-enforcement:Z-2697-2014

Official wording

Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Code information: 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.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.