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U.S. Department of Health and Human Services

Class 2 Device Recall ANGIODYNAMICS BENEPHIT(TM) XT Infusion System

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  Class 2 Device Recall ANGIODYNAMICS BENEPHIT(TM) XT Infusion System see related information
Date Initiated by Firm April 30, 2010
Date Posted May 28, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-1734-2010
Recall Event ID 55713
510(K)Number K082163  K050205  K033569  
Product Classification Catheter, continuous flush - Product Code KRA
Product ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Catalog/Model/REF Number 60035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.
Code Information Batch Number: P909231.
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Avenue
Queensbury NY 12804
For Additional Information Contact S. Michael Sharp, PhD, FRAPS
518-798-1123
Manufacturer Reason
for Recall		 Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.
FDA Determined
Cause 2		 Packaging change control
Action Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.
Quantity in Commerce 22
Distribution Distributed Nationwide and to Italy
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 = KRA and Original Applicant = FLOWMEDICA, INC.
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