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U.S. Department of Health and Human Services

Class 2 Device Recall BioStable 5F DL55CM MST70 KIT NonValved PG

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  Class 2 Device Recall BioStable 5F DL55CM MST70 KIT NonValved PG see related information
Date Initiated by Firm November 28, 2016
Create Date December 14, 2017
Recall Status1 Terminated 3 on June 12, 2019
Recall Number Z-0246-2018
Recall Event ID 76570
510(K)Number K150448  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871

The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
Code Information Lot 4897789
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		 Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
FDA Determined
Cause 2		 Component design/selection
Action The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to 1. IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company) o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. o If affected product is located in your institution, 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. o 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. o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product to: AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator. If you have any questions, please call: 518-795-1358 or 518-795-1116.
Quantity in Commerce 4591 units in total
Distribution Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
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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