Events

Recall of VAGINAL DELIVERY 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
    74350
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-20
  • 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
    Bd canada issued a product advisory notice regarding the bd vacutainer luer adapter cat. no. 367290 and bd vacutainer specimen collection assembly with bd blunt plastic cannula cat. no. 303380. bd has received reports of blood leakage and low draw volume associated with the bd vacutainer luer adapter and bd vacutainer specimen collection assembly with bd blunt plastic cannula. in a limited number of instances the gray rubber sleeve on the cannula inside of the vacutainer tube holder has been reported to disengage from the cannula or permit small amounts of blood leakage during the collection of multiple tubes. the bd vacutainer luer adapter cat. no. 367290 is a component in the medline vaginal delivery cds module cds982079b.

Device

VAGINAL DELIVERY CDS PACK
  • Model / Serial
    Model Catalog: CDS982079B (Lot serial: 12EB1869); Model Catalog: CDS982079B (Lot serial: 12EB0522); Model Catalog: CDS982079B (Lot serial: 12CD3095); Model Catalog: CDS982079B (Lot serial: 12EB2281); Model Catalog: CDS982079B (Lot serial: 12EB2222)
  • Product Description
    Vaginal Delivery CDS Module
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION