Events

Recall of MEDITRON IRRIGATION TRAY WITH BULB SYRINGE

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
    142906
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-02
  • 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 kits contain aplicare povidone iodine prep pads which are being recalled due to stability test results. during ongoing stability studies it was discovered that the aplicare povidone iodine prep pads (npn 02076152 product code p-1011) failed to support the 36 month expiry dating of the product. the product does support a 24 month expiration date.

Device

MEDITRON IRRIGATION TRAY WITH BULB SYRINGE
  • Model / Serial
    Model Catalog: M103121X (Lot serial: ALL LOTS); Model Catalog: M103120X (Lot serial: ALL LOTS); Model Catalog: M101345 (Lot serial: ALL LOTS); Model Catalog: DYNDCA20100 (Lot serial: ALL LOTS)
  • Product Description
    IRRIGATION TRAY;IV START KIT;BULB SYRINGE IRRIGATION TRAY
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION