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U.S. Department of Health and Human Services

Class 2 Device Recall Navilyst Medical BioFlo PICC with ENDEXO and PASV

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  Class 2 Device Recall Navilyst Medical BioFlo PICC with ENDEXO and PASV see related information
Date Initiated by Firm October 16, 2018
Create Date December 11, 2018
Recall Status1 Terminated 3 on June 26, 2020
Recall Number Z-0596-2019
Recall Event ID 81477
510(K)Number K121990  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL
SYSTEM (LTP) PG) Cat. no. 60M183481
Code Information 5231609
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact Mr. Warren Nighan
508-658-7940
Manufacturer Reason
for Recall		 specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
FDA Determined
Cause 2		 Under Investigation by firm
Action On October 16, 2018, the firm issued Urgent Voluntary Medical Device Recall letters to affected customers. The letter identified the product issue. Customers were asked to do take the following immediate actions: 1. Actions to be taken IMMEDIATELY: - Stop using the product subject to recall. - Remove any affected (recalled) 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 AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have distributed affected product. - No actions are required on product that has been used or is presently in-use; the affected product is within its validated expiry 2. Complete and return the Reply Verification Tracking Form. - For any affected product to be returned, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) 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); following the directions on this page and the Reply Verification Tracking Form. - Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com - Fax Reply Verification Tracking Form: Attn: Xcela and BioFlo Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. - Please use our FedEx Account Number (284750594) to return this package via second day delivery. - Seal the box and return to: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 Attn: Xcela and BioFlo Re
Quantity in Commerce Box of 4 units
Distribution Distributed to accounts in Florida. Foreign distribution to Great Britain.
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 = LJS and Original Applicant = NAVILYST MEDICAL, INC.
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