Events

Recall of OPEN HEART 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
    27968
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-17
  • 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 industries received a recall notice from medtronic concerning the covidien devon light glove. the light glove may split upon application to the devon light handle adapter. the light glove is a component in several medline custom or procedure packs.

Device

OPEN HEART PACK
  • Model / Serial
    Model Catalog: DYNJ33026X (Lot serial: CONTACT MFG); Model Catalog: DYNJ40048X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41960X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46813X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46796X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46801X (Lot serial: CONTACT MFG); Model Catalog: DYNJ50394X (Lot serial: CONTACT MFG); Model Catalog: DYNJS0910 (Lot serial: CONTACT MFG); Model Catalog: DYNJ48194X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46791X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46802X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46792X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46810X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41945X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46799X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41952X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46798X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41668X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41679X (Lot serial: CONTACT MFG); Model Catalog: DY
  • Product Description
    OPEN HEART PACK;CABG PACK;UROLOGY MAJOR PACK LF;MINOR BASIC LH-LF;DHS VERSAFIX LH-LF;VAG HYSTERECTOMY LH-LF;EVAR PACK;LAPAROSCOPY TRAY;ROBOTICS PACK WRM-LF;ADULT HERNIA LH-LF;TUBAL LIGATION LH-LF;PERCUTANEOUS NEPHRO LH-LF;TVT KIT LAKERIDGE LH-LF;BREAST PA
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION