Events

Recall of Device Recall XCELA PASV 5F DL 55CM IR145 KIT PG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics Inc. (Navilyst Medical Inc.).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76570
  • Event Risk Class
    Class 2
  • Event Number
    Z-0243-2018
  • Event Initiated Date
    2016-11-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160029
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    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.
  • 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.

Device

Device Recall XCELA PASV 5F DL 55CM IR145 KIT PG
  • Model / Serial
    Lot 4899431
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
  • Product Description
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 || 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.
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • Manufacturer Address
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA