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U.S. Department of Health and Human Services

Class 2 Device Recall UNIFUSE INFUSION SYSTEM

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  Class 2 Device Recall UNIFUSE INFUSION SYSTEM see related information
Date Initiated by Firm January 28, 2011
Date Posted September 19, 2011
Recall Status1 Terminated 3 on October 18, 2012
Recall Number Z-3267-2011
Recall Event ID 59820
510(K)Number K951509  
Product Classification Catheter, continuous flush - Product Code KRA
Product ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804
Code Information Lot 521372 (Use By 2013-07)
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
Manufacturer Reason
for Recall		 The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.
FDA Determined
Cause 2		 Employee error
Action URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.
Quantity in Commerce 24 units
Distribution Worldwide Distribution -- USA and The Netherlands.
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 = ANGIODYNAMICS, DIV. E-Z-EM, INC.
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