Events

Recall of ACLAIM 2 CPAP MASK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER AND PAYKEL HEALTHCARE LTD..

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
    97707
  • Event Risk Class
    II
  • Event Initiated Date
    2006-12-07
  • 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
    Connector component used in a previous version of its cpap masks may fail prematurely if improperly cleaned.

Device

ACLAIM 2 CPAP MASK
  • Model / Serial
    Model Catalog: HC401A (Lot serial: 900HC402 LOT#010918 TO 060203); Model Catalog: HC401A (Lot serial: 900HC412 LOT#020108 TO 060203); Model Catalog: HC401A (Lot serial: 900HC401X LOT#010829 TO 020517); Model Catalog: HC401A (Lot serial: HC401A LOT#020521 TO 060217); Model Catalog: HC452F (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC451A (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451T (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: 900HC451 (Lot serial: 900HC463 LOT#020108 TO 040604); Model Catalog: HC452F (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC451A (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451T (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: 900HC451 (Lot serial: 400HC209 LOT#041108 TO 050920); Model Catalog: HC452F (Lot serial: HC452F LOT#040719 TO 041102); Model Catal
  • Product Description
    ACLAIM 2 CPAP MASK
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.