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U.S. Department of Health and Human Services

Class 2 Device Recall UltraStream Chronic Hemodialysis Catheter

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  Class 2 Device Recall UltraStream Chronic Hemodialysis Catheter 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-2696-2014
Recall Event ID 68521
510(K)Number K102043  K023847  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
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.
Code Information 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.
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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