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Terminated

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 Recall Z-2697-2014 · Posted 2014-09-24

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeMSD
Date Initiated2014-06-05
Date Terminated2015-04-08
Product Quantity3,783 units

Reason for Recall

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

Root Cause

Component design/selection

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERRex Medical · 2010-11-18K023847HEMO-STREAM HEMODIALYSIS CATHETER SETRex Medical · 2003-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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