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U.S. Department of Health and Human Services

Class 2 Device Recall UniFuse Infusion System with Cooper Wire

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  Class 2 Device Recall UniFuse Infusion System with Cooper Wire see related information
Date Initiated by Firm August 06, 2014
Date Posted August 18, 2014
Recall Status1 Terminated 3 on March 27, 2017
Recall Number Z-2261-2014
Recall Event ID 68980
510(K)Number K951602  K905447  K961763  
Product Classification Catheter, continuous flush - Product Code KRA
Product Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Code Information Lot 4731641 (exp. date 31-Mar-17)
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact Michael Duerr
518-742-4571
Manufacturer Reason
for Recall		 AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
FDA Determined
Cause 2		 Component design/selection
Action AngioDynamics sent an URGENT MEDICAL DEVICE RECALL Letter dated August 6, 2014, to all affected customers via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics, Inc. and complete and return the Reply Verification Tracking Form, provided in the recall notification. Those customers with the affected product were also instructed to call AngioDynamics Customer Service at 1-800-772-6446. For questions regarding this recall call 718-742-4571.
Quantity in Commerce Domestic: 81 units; Foreign: 13 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
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.
510(K)s with Product Code = KRA and Original Applicant = E-Z-EM, INC.
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