Events

Recall of Device Recall Mentor Aseptic Transfer Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mentor Texas, 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
    49522
  • Event Risk Class
    Class 2
  • Event Number
    Z-0407-2009
  • Event Initiated Date
    2008-08-22
  • Event Date Posted
    2008-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73723
  • 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
    Aseptic Transfer Set - Product Code GAZ
  • Reason
    The mentor aseptic transfer set contains a component, the bd 60ml luer-lok syringe, which is under recall by becton dickinson due to a package integrity issue.
  • Action
    Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.

Device

Device Recall Mentor Aseptic Transfer Set
  • Model / Serial
    Aseptic Transfer Sets: All lots.  Syringes: Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and South Africa.
  • Product Description
    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
  • Manufacturer
    Mentor Texas, Inc

Manufacturer

Mentor Texas, Inc
  • Manufacturer Address
    Mentor Texas, Inc, 3041 Skyway Cir N, Irving TX 75038-3500
  • Source
    USFDA