Events

Recall of CONTACT DETACH INFUSION SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC..

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
    90242
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-24
  • 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
    Manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location. if tubing detachment occurs insulin delivery is interrupted and the pump will not alarm to notify patients. the interruption of insulin delivery can cause hyperglycemia which if left untreated can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health including death. symptoms of dka may include nausea vomiting shortness of breath and excess thirst/urination. manufacturer is advising patients to seek medical attention immediately if they are experiencing any of these symptoms.

Device

CONTACT DETACH INFUSION SETS
  • Model / Serial
    Model Catalog: 10090503 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000601 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000602 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000603 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000600 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090502 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090500 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024005 (Lot serial: 5052070); Model Catalog: 10024004 (Lot serial: 5052070); Model Catalog: 10024003 (Lot serial: 5052070); Model Catalog: 10024001 (Lot serial: 5052070); Model Catalog: 89-060-2522 (Lot serial: 5052070); Model Catalog: 10024005 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024004 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024003 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 89
  • Product Description
    Contact Detach Infusion Sets
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.