Events

Recall of Device Recall Oracle Oral Mask

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher & Paykel Healthcare 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
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49664
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.

Device

Device Recall Oracle Oral Mask
  • Model / Serial
    Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016), 900HC451T (lot #s: 011024 to 020517), HC451A (lot #s: 020523 to 040907), HC452A (lot #s: 031215 to 060503) & HC452F (lot #s: 040719 to 041102)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc
  • Manufacturer Address
    Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
  • Source
    USFDA