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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC Fluid Delivery Set

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  Class 2 Device Recall NAMIC Fluid Delivery Set see related information
Date Initiated by Firm January 13, 2017
Date Posted March 29, 2017
Recall Status1 Terminated 3 on June 25, 2018
Recall Number Z-1853-2017
Recall Event ID 76347
510(K)Number K852140  
Product Classification Set, administration, intravascular - Product Code FPA
Product NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Code Information Lot Number: 5122528
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact
800-772-6446
Manufacturer Reason
for Recall		 The product has the potential to be non-sterile as it was not packaged in accordance to specification.
FDA Determined
Cause 2		 Under Investigation by firm
Action On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.
Quantity in Commerce 8 boxes/25 units
Distribution CA, KY, MD, OR, VA, 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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = NORTH AMERICAN INSTRUMENT CORP.
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