Events

Recall of Device Recall Adelante

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oscor, 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
    49558
  • Event Risk Class
    Class 2
  • Event Number
    Z-0130-2009
  • Event Initiated Date
    2008-07-03
  • Event Date Posted
    2008-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73810
  • 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
    introducer set - Product Code DYB
  • Reason
    Difficulty breaking the sheath hub and subsequently to peel the sheath off for introducer set, adelante size 7f.
  • Action
    Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.

Device

Device Recall Adelante
  • Model / Serial
    Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to one direct account in MN.
  • Product Description
    Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
  • Manufacturer
    Oscor, Inc.

Manufacturer

Oscor, Inc.
  • Manufacturer Address
    Oscor, Inc., 3816 Desoto Blvd, Palm Harbor FL 34683
  • Manufacturer Parent Company (2017)
    Oscor Inc.
  • Source
    USFDA