Events

Recall of Device Recall VisuaLine Propoxyphene;

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sun Biomedical Laboratories, 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
    48464
  • Event Risk Class
    Class 2
  • Event Number
    Z-1874-2008
  • Event Initiated Date
    2008-05-28
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71479
  • 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
    Propoxyphene enzyme immunoassay - Product Code JXN
  • Reason
    Product was sold while the devices were under fda 510 (k) review, which was subsequently denied.
  • Action
    On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.

Device

Device Recall VisuaLine Propoxyphene;
  • Model / Serial
    Sun Biomedical Part #: 15-2017, lot number: Vis-PPX Dip 07-094-1-85.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Product Description
    VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
  • Manufacturer
    Sun Biomedical Laboratories, Inc.

Manufacturer

Sun Biomedical Laboratories, Inc.
  • Manufacturer Address
    Sun Biomedical Laboratories, Inc., 1001 Lower Landing Rd, Blackwood NJ 08012-3124
  • Source
    USFDA