| Class 2 Device Recall UltraStream Chronic Hemodialysis Catheter | |
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 | K023847 K102043 |
Product Classification |
Catheter, hemodialysis, implanted - Product Code MSD
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MSD
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