UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 320
FDA device recall Z-2697-2014 · posted 2014-09-24 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 3,783 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-06-05
- Date posted
- 2014-09-24
- Date terminated
- 2015-04-08
- Location
- Athens, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER (K102043) | Rex Medical | 2010-11-18 |
| HEMO-STREAM HEMODIALYSIS CATHETER SET (K023847) | Rex Medical | 2003-04-30 |