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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC Convenience Kit

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  Class 2 Device Recall NAMIC Convenience Kit see related information
Date Initiated by Firm November 03, 2015
Date Posted April 07, 2016
Recall Status1 Terminated 3 on March 16, 2017
Recall Number Z-1346-2016
Recall Event ID 72957
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF
Catalog No. 601319810, UPN Product No. H7496013198101

Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.
Code Information Batch/Lot No. 4931728, 4933094; Use By 2017-03
Recalling Firm/
Manufacturer		 AngioDynamics Inc.
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact Keith J. McKenna
518-742-4344
Manufacturer Reason
for Recall		 Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
FDA Determined
Cause 2		 Process control
Action On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday EST) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to rdenino@angiodynamics.com or sbaxter@angiodynamics.com.
Quantity in Commerce 45 kits
Distribution US Nationwide in the states of CA, IL, MA, SC, TX
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.
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