Events

Recall of Device Recall 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
    28678
  • Event Risk Class
    Class 2
  • Event Number
    Z-0772-04
  • Event Initiated Date
    2004-03-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32331
  • 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
    Catheter, Ventricular - Product Code HCA
  • Reason
    Drainage tips absent from catheter tip.
  • Action
    Codman telephoned direct customers by telphone on 3/11/04. Accounts were requested to return product.

Device

Device Recall Codman
  • Model / Serial
    Lot Number: 1106525
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, GA, MI, ,NC, SC, TN, TX Foreign: Italy and Germany
  • Product Description
    Codman Holter Salmon Rickham Reservoir with Ventricular Catheter || Catalog Number: 82-1617
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

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