—#128133

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.

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K023847, K102043
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2014-06-05
Posted by FDA: 2014-09-24
Terminated: 2015-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128133. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.