Events

Recall of INCA INFANT NASAL CANNULAE ASSEMBLY FOR CPAP 7.5F

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERSURGICAL 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
    45311
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-20
  • 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
    There is potential for the "t" pressure adaptor a component of the inca infant nasal cannulae assemblies for cpapto have an obstruction in the outlet used for pressure monitoring. the injection mold tooling was identified to sporadically and in very limited. quatities create pieces ("t" pressure adaptors) where the in-pin insert was not sliding completely to its end point in the tool causing the obstruction in the outlet.

Device

INCA INFANT NASAL CANNULAE ASSEMBLY FOR CPAP 7.5F
  • Model / Serial
    Model Catalog: AL-44-2707 (Lot serial: ); Model Catalog: AL-44-2712 (Lot serial: 82084); Model Catalog: AL-44-2712 (Lot serial: 69952); Model Catalog: AL-44-2715 (Lot serial: 81162); Model Catalog: AL-44-2715 (Lot serial: 82090); Model Catalog: AL-44-2712 (Lot serial: 83973); Model Catalog: AL-44-2710 (Lot serial: 82082); Model Catalog: AL-44-2709 (Lot serial: 82080); Model Catalog: AL-44-2709 (Lot serial: 82081)
  • Product Description
    INCA Infant Nasal Cannulae Assembly for CPAP 7.5F
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.