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U.S. Department of Health and Human Services

Class 2 Device Recall UltraStream Exchange Kit

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  Class 2 Device Recall UltraStream Exchange Kit see related information
Date Initiated by Firm June 05, 2014
Date Posted September 24, 2014
Recall Status1 Terminated 3 on April 08, 2015
Recall Number Z-2697-2014
Recall Event ID 68521
510(K)Number K102043  K023847  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product 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.
Code Information Lot Numbers: 11029949, 11031335, 11033533, 11035161, 11036607, 11037817, 11039719, 11040058, 11042305, 11044092, 11046743, 11048076, 11049066, 11056427, 11059461, 11024109, 11025359, 11027376, 11028490, 11029950, 11031336, 11034141, 11036893, 11037742, 11038551, 11039237, 11039524, 11039864, 11042306, 11044337, 11048077, 11048786, 11050038, 11054478, 11057548, 11057763, 11059464, 11028491, 11032828, 11034343, 11038165, 11040263, 11042555, 11043587, 11044382, 11047358, 11048923, 11050289, 11054889, 11059622, 11065827, 11035772, 11037651, 11040943, 11059624, 11035771, 11041993, 11050454, 11059467.
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Lance Borden
903-468-1858
Manufacturer Reason
for Recall		 UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
FDA Determined
Cause 2		 Component design/selection
Quantity in Commerce 3,783 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSD and Original Applicant = REX MEDICAL
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