—#128134

Product

UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

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: 11030816, 11031844, 11032797, 11033587, 11033816, 11034388, 11035767, 11038234, 11038335, 11039565, 11041289, 11041994, 11043179, 11044967, 11045825, 11048504, 11049437, 11049775, 11050202, 11051294, 11054323, 11055558, 11057594, 11059629, 11061076, 11063899, 11067036, 11025361, 11030817, 11031845, 11032798, 11033391, 11033945, 11034347, 11035769, 11036779, 11038235, 11038990, 11040156, 11041290, 11044061, 11045091, 11046609, 11047537, 11049868, 11050802, 11053027, 11053781, 11054547, 11054548, 11055303, 11056428, 11059470, 11062800, 11067037, 11030950, 11032799, 11033588, 11034388, 11035770, 11038236, 11039238, 11039865, 11041803, 11043180, 11046290, 11047538, 11049299, 11051665, 11055890, 11059471, 11035019, 11037137, 11041292, 11044061, 11056430, 11059473, 11031846, 11035968, 11038663, 11044540, 11046906, 11049669, 11054377, 11059472.

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 #128134. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.