Recalls / —
—#128132
Product
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (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: 11034387, 11034915, 11039525, 11045439, 11057890, 11059625, 11027376, 11034000, 11035976, 11036453, 11038334, 11041518, 11044383, 11047511, 11049668, 11052111, 11054546, 11059459, 11060050, 11033757, 11041251, 11044868, 11050693, 11054199, 11059627, 11061874, 11067035, 11021364, 11034424, 11059468, 11034914, 11035965.
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 #128132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.