FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Inc: Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.
- Recall number
- Z-0972-2007
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Product
- Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.
- Status
- Terminated
- Initiated
- 2006-11-24
- Posted
- 2007-06-27
- Terminated
- 2012-03-26
- 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
- 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
- 815,239 total for all models, all lots
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot numbers for Part Numbers: HC481A (lot #s:050128 to 060506) & HC481SL (lot #s: 050608 to 060327)
- 510(k) numbers
- ["K003894","K033087","K040506"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 3000210616
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28