Events

Recall of NON-DEHP MICROBORE ADMINISTRATION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LYNDEN INTERNATIONAL LOGISTICS CO..

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
    16735
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-30
  • 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
    A defect with the resin used in tubing received from a supplier has been discovered. this has resulted in a rough texture on the inner and outer diameter of the tubing segment inserted into the pump. this could lead to the pump sensor registering an air bubble causing an unresolvable false air-in-line alarm even if no air bubble is present.

Device

NON-DEHP MICROBORE ADMINISTRATION SET
  • Model / Serial
    Model Catalog: 340-4168 (Lot serial: D100712); Model Catalog: 340-4126 (Lot serial: D024513); Model Catalog: 340-4126 (Lot serial: CF1020901); Model Catalog: 340-4126 (Lot serial: D017913); Model Catalog: 340-4126 (Lot serial: D016002); Model Catalog: 340-4126 (Lot serial: CF10120003); Model Catalog: 340-4126 (Lot serial: D015326); Model Catalog: 340-4126 (Lot serial: D013714); Model Catalog: 340-4126 (Lot serial: D010416); Model Catalog: 340-4126 (Lot serial: D010321); Model Catalog: 340-4115 (Lot serial: D004616); Model Catalog: 340-4134 (Lot serial: D008511); Model Catalog: 340-4115 (Lot serial: D008511); Model Catalog: 340-4134 (Lot serial: D010911); Model Catalog: 340-4115 (Lot serial: D010911); Model Catalog: 340-4134 (Lot serial: D017418); Model Catalog: 340-4115 (Lot serial: D017418); Model Catalog: 340-4134 (Lot serial: D004616); Model Catalog: 340-4115 (Lot serial: D017317); Model Catalog: 340-4134 (Lot serial: D017317)
  • Product Description
    NON-DEHP MICROBORE ADMINISTRATION SET
  • Manufacturer
    LYNDEN INTERNATIONAL LOGISTICS CO.

Manufacturer

LYNDEN INTERNATIONAL LOGISTICS CO.