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U.S. Department of Health and Human Services

Class 2 Device Recall UltraStream Peel Away Kit

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  Class 2 Device Recall UltraStream Peel Away 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-2698-2014
Recall Event ID 68521
510(K)Number K102043  K023847  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (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: 11030816, 11031844, 11032797, 11033587, 11033816, 11034388, 11035767, 11038234, 11038335, 11039565, 11041289, 11041994, 11043179, 11044967, 11045825, 11048504, 11049437, 11049775, 11050202, 11051294, 11054323, 11055558, 11057594, 11059629, 11061076, 11063899, 11067036, 11025361, 11030817, 11031845, 11032798, 11033391, 11033945, 11034347, 11035769, 11036779, 11038235, 11038990, 11040156, 11041290, 11044061, 11045091, 11046609, 11047537, 11049868, 11050802, 11053027, 11053781, 11054547, 11054548, 11055303, 11056428, 11059470, 11062800, 11067037, 11030950, 11032799, 11033588, 11034388, 11035770, 11038236, 11039238, 11039865, 11041803, 11043180, 11046290, 11047538, 11049299, 11051665, 11055890, 11059471, 11035019, 11037137, 11041292, 11044061, 11056430, 11059473, 11031846, 11035968, 11038663, 11044540, 11046906, 11049669, 11054377, 11059472.
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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