Events

Recall of Device Recall Elefant Suction Irrigation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Corp.

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
    45907
  • Event Risk Class
    Class 2
  • Event Number
    Z-0714-2008
  • Event Initiated Date
    2007-11-12
  • Event Date Posted
    2008-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66463
  • 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
    Suction Irrigation Device for Laparoscopy - Product Code FQH
  • Reason
    Lack of sterilization assurance: sterilization of elefant suction-irrigation devices is not performed according to iso 11135 standard.
  • Action
    Coloplast sent customers an "Urgent: Recall Notification" letter on 11/12/07. The letter described that the sterilization of the products was not performed according to ISO 11135 standard. The notification requested the customers to return the product immediately and to send a fax or contact the company via email in regard to inventory at hand. A phone script for distributors also included an advice to discontinue dispensing the product and to fax or email in regard to inventory at hand.

Device

Device Recall Elefant Suction Irrigation Device
  • Model / Serial
    All un-expired lots are being recalled.   ASP 165: Lot Serial# 04023897 6120192 7021217 7053185 7062896 7062897 7062903 7070016 ASP16502002 ASP16502005 ASP16503040 ASP16503043 ASP16503101459 ASP16503110460 ASP16504023143 ASP16504023897 ASP16504033803 ASP16504061589 ASP16504064478 ASP16504070805 ASP16504074192 ASP1655021255 ASP1655030739 ASP1655031634 ASP1655042461 ASP1655051481 ASP1655052172 ASP1655052174 ASP1655052175 ASP1655052651 ASP1655053628 ASP1655060297 ASP1655060299 ASP1655062276 ASP1655062277 ASP1655070732 ASP1656100365 ASP1656100366 ASP1656120191 ASP1657010843 ASP1657021217 ASP 170: Lot Serial # ASP1701000
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico.
  • Product Description
    Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: || ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411
  • Manufacturer
    Coloplast Corp

Manufacturer

Coloplast Corp
  • Manufacturer Address
    Coloplast Corp, 1525 W River Rd, Minneapolis MN 55411-3430
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA