Z-0974-2007

Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203...

Name: Z-0974-2007 Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203...
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 Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452... 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-0974-2007
Status: Terminated
Initiated: 2006-11-24
Posted: 2007-06-27
Terminated: 2012-03-26
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). 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: 400HC202 (lot #s: 040802 to 051222),400HC203 (lot #s: 040719 to 051103), 400HC209 (lot #s: 041108 to 050920), 400HC502 (lot #s: 040825 to 060201), 400HC503 (lot #s:040830 to 051028), 400HC505 (lot #s: 050223 to 050726), 400HCHC510 (lot #s: 051007 to 051028) , 900HC402 (lot #s: 010918 to 060203), 900HC405 (lot#s: 030924 to 030925), 900HC406 (lot #s: 031110 to 060403), 900HC412 (lot #s: 020108 to 060203), 900HC441 (lot #s: 031110 to 060424) & 900HC463 (lot #s: 020108 to 040604)

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)