Events

Recall of Introducer, Catheter

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
    34123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0345-06
  • Event Initiated Date
    2005-09-13
  • Event Date Posted
    2006-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43162
  • 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, Catheter - Product Code DYB
  • Reason
    Sheath size is larger than dilator size causing insertion difficulties.
  • Action
    The firm will issue a recall letter to its consignees informing them of the recall. The letter will ask the consignees to return the devices from affected lot numbers for replacement. The returned products will be individually inspected.

Device

Introducer, Catheter
  • Model / Serial
    BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
  • Product Description
    Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
  • Manufacturer
    Oscor Inc.

Manufacturer

Oscor Inc.
  • Manufacturer Address
    Oscor Inc., 3816 De Soto Blvd, Palm Harbor FL 34683-1618
  • Source
    USFDA