Z-0971-2007

Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A...

Name: Z-0971-2007 Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A...
Creator: Fisher & Paykel Healthcare Inc
Published: 2006-11-24
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2006-11-24 / Terminated / root cause: labeling and UDI

FDA source

Fisher & Paykel Healthcare Inc began a recall of Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks on 2006-11-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0971-2007
Status: Terminated
Initiated: 2006-11-24
Posted: 2007-06-27
Terminated: 2012-03-26
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 815,239 total for all models, all lots
Distribution: Nationwide
Product codes and lots: Lot numbers for Part Numbers: HC405A (lot #s: 020930 to 060410) , HC405SL (lot #s: 040225 to 040325), HC405U (lot #s: 030922 to 060217), HCHC406A (lot #s: 050830 to 060123), HC406SL (lot #s: 051021 to 051220), HC407A (lot #s: 031124 to 060207), HC407SL (lot #s: 040921 to 060202) & HC407U (lot #s: 040407 to 060113)

Product code BZD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)