| Class 2 Device Recall UltraStream Peel Away Kit | |
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 | K023847 K102043 |
Product Classification |
Catheter, hemodialysis, implanted - Product Code MSD
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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
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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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