RecallRadar

FDA Device recall Z-2696-2014

UltraStream Chronic Hemodialysis Catheter Standard Kit

On 2014-10-01 the FDA classified a Class II recall of UltraStream Chronic Hemodialysis Catheter Standard Kit by Argon Medical Devices, citing ultraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2696-2014
ClassificationClass II
Statusterminated
Initiated2014-06-05
Published2014-10-01
Last updated2026-09-13 11:53 UTC
CompanyArgon Medical Devices
DistributionUS

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.

Reason

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

Identifiers

code_info
Lot Numbers: 11034387, 11034915, 11039525, 11045439, 11057890, 11059625, 11027376, 11034000, 11035976, 1103645…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2696-2014%22

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