Events

Recall of Device Recall Xcela 5FDL55cm Maximal Barrier Nursing 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
    80169
  • Event Risk Class
    Class 2
  • Event Number
    Z-2220-2018
  • Event Initiated Date
    2018-05-10
  • 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=164759
  • 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
    A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
  • Action
    Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: 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. Complete and return the Reply Verification Tracking Form. 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.

Device

Device Recall Xcela 5FDL55cm Maximal Barrier Nursing Kit PG
  • Model / Serial
    UPN: H965750031; Lot: 5301074, 5304327, 5308920
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
  • Product Description
    Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
  • 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