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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC (TM) Convenience Kit

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  Class 2 Device Recall NAMIC (TM) Convenience Kit see related information
Date Initiated by Firm January 09, 2015
Date Posted February 26, 2015
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-1201-2015
Recall Event ID 70322
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.

NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
Code Information Lots 4653565 and 4653754 
Recalling Firm/
Manufacturer
Navilyst Medical, Inc
10 Glens Falls Technical Park
Glens Falls NY 12801
For Additional Information Contact
518-792-4112
Manufacturer Reason
for Recall
The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.
FDA Determined
Cause 2
Packaging
Action Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.
Quantity in Commerce 70 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
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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