Events

Recall of Codman

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codman & Shurtleff, 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
    36045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1533-06
  • Event Initiated Date
    2006-08-04
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47830
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Sterility of device is compromised due to package seal defects.
  • Action
    Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax.

Device

Codman
  • Model / Serial
    Lot Number: CGHBKY
  • Product Classification
    Neurological Devices
  • Distribution
    Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
  • Product Description
    Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter || Catalog Numer: 82-1730
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Manufacturer Address
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767-5199
  • Source
    USFDA