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U.S. Department of Health and Human Services

Class 2 Device Recall PULSESPRAY INFUSION SYSTEM

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  Class 2 Device Recall PULSESPRAY INFUSION SYSTEM see related information
Date Initiated by Firm May 17, 2010
Date Posted May 27, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-1707-2010
Recall Event ID 55715
510(K)Number K905447  
Product Classification Catheter, continuous flush - Product Code KRA
Product PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804.

Infusion Catheter.
Code Information Lot Number: 991437.
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Avenue
Queensbury NY 12804
For Additional Information Contact S. Michael Sharp, PhD, FRAPS
518-795-1123
Manufacturer Reason
for Recall		 This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.
FDA Determined
Cause 2		 Process control
Action Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax. For further information, contact Angiodynamics Customer Service at 1-800-772-6446.
Quantity in Commerce 20 units
Distribution Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
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 = E-Z-EM, INC.
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