FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 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.
- Recall number
- Z-2696-2014
- Recalling firm
- Argon Medical Devices, Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-06-05
- Posted
- 2014-09-24
- Terminated
- 2015-04-08
- Reason
- UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
- Root cause
- Component design/selection
- Action
- not on file
- Quantity
- 3,783 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K023847","K102043"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28