Events

Recall of Brodmerkel Colon Decompression Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wilson-Cook Medical 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
    27449
  • Event Risk Class
    Class 3
  • Event Number
    Z-0048-04
  • Event Initiated Date
    2003-10-08
  • Event Date Posted
    2003-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29897
  • 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
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation - Product Code FEG
  • Reason
    Product may be packaged with an incorrect instructions for use (ifu) booklet.
  • Action
    Recall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.

Device

Brodmerkel Colon Decompression Set
  • Model / Serial
    Catalog # CDSB-10, Lot #1589467
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to Hospitals located in CA, NC, PA, and WI.
  • Product Description
    Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable ¿ Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • Manufacturer Address
    Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
  • Source
    USFDA