Events

Recall of GENERAL LAPAROSCOPY CDS PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    20754
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Medline has received a recall notice from conmed regarding their core reposable trumpet handpiece (conmed p/n cd8300). these handpieces are used as a component in several cds modules sold by medline canada. conmed is issuing this recall because the individual package seal may be compromised which could potentially affect the integrity of the sterile barrier. the handpieces are to be removed from the packs upon opening and discarded. the medline pack has been terminally sterilized therefore the remaining components within the pack are safe to use.

Device

GENERAL LAPAROSCOPY CDS PACK
  • Model / Serial
    Model Catalog: CDS983989 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983989A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007B (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983995 (Lot serial: 13BB3793); Model Catalog: CDS983995 (Lot serial: 13BB9766); Model Catalog: CDS983995 (Lot serial: 13MB1943); Model Catalog: CDS983995 (Lot serial: 13SB1980); Model Catalog: CDS983995 (Lot serial: 12JB8722)
  • Product Description
    GENERAL LAPAROSCOPY CDS PACK;MAJOR GYN LAPAROSCOPY CDS PACK;MINOR GYN LAPAROSCOPY CDS PACK
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION