Events

Recall of C - SECTION 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
    15298
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-25
  • 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
    The pack contains a vacutainer manufactured by bd. the bd lav top vacutainer k2 plus blood collection tube is recalled by bd because some lots were manufactured with insufficient edta additive. according to bd insufficient edta additive could lead to erroneous results. lots 15wb7898 and 15wb9865 of medline pack dynj41766a contain one of the affected bd vacutainers catalogue number 367844 lot. no. 5154624.

Device

C - SECTION PACK
  • Model / Serial
    Model Catalog: DYNJ41766X (Lot serial: 15WB9865); Model Catalog: DYNJ41766X (Lot serial: 15WB7898)
  • Product Description
    C SECTION PACK CKHA-LF
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION