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
    25828
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-30
  • 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
    These packs contain a light handle cover manufactured by medtronic (formerly covidien). the covidien devont light handle cover is a sterile plastic sheath that slides over the handle of the overhead surgical light. it allows a gloved surgeon or or nurse to grab the handle with sterile gloves to maintain sterility. medtronic has initiated a voluntary recall of the light handle cover due to potential defects that may compromise the integrity of the product. a copy of medtronic's recall letter is attached.

Device

OPEN HEART PACK
  • Model / Serial
    Model Catalog: DYNJ33026X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41666X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ33288X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ47601X (Lot serial: 14JB6768); Model Catalog: DYNJ46799X (Lot serial: 15MB6363); Model Catalog: DYNJ47601X (Lot serial: 14GB4580); Model Catalog: DYNJ46813X (Lot serial: 15CB7129); Model Catalog: DYNJ46813X (Lot serial: 14LB10457); Model Catalog: DYNJ46796X (Lot serial: 15BB7629); Model Catalog: DYNJ46801X (Lot serial: 15OB3443); Model Catalog: DYNJ46801X (Lot serial: 15NB1069); Model Catalog: DYNJ46801X (Lot serial: 14LB1053); Model Catalog: DYNJ40049X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41834X (Lot serial: 13TB1836); Model Catalog: DYNJ47601X (Lot serial: 14HB8722); Model Catalog: DYNJ41679X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41668X (Lot serial: 13IB1520); Model Catalog: DYNJ41668X (Lot serial: 13JB2275); Model Catalog: DYNJ41668X (Lot serial: 14MB0571
  • Product Description
    Open Heart Pack
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION