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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC

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  Class 2 Device Recall NAMIC see related information
Date Initiated by Firm January 18, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on September 21, 2018
Recall Number Z-1390-2018
Recall Event ID 79558
Product Classification Angiography/angioplasty kit - Product Code OEQ
Product Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management
and/or Invasive Pressure Monitoring systems.
Code Information Lot Numbers: 5284422 5286610 5283649 5290525 5286542 
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact
518-792-4112
Manufacturer Reason
for Recall		 NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.
Quantity in Commerce 38 units
Distribution Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
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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