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CPAP masks - various Fisher and Paykel

Medical device recall
Published
Level: Consumer
Class: III
Reference: RN-2006-0772
Date agreed: 24 November 2006
Product:

Various Fisher and Paykel CPAP masks:

Nasal Mask (HC401A)
Nasal Mask (HC401U)
Nasal Mask (HC405A)
Nasal Mask (HC406A)
Nasal Mask (HC407A)
NIV Nasal Mask (HC407NIVB)
Full Face Mask (HC431A)
Full Face Mask (HC431B)
NIV Full Face Mask (HC431NIVB)
Oral Mask (HC451U)
Oral Mask (HC452A)
Oral Mask (HC452B)
NIV Oral Mask (HC452NIVB)
Direct Nasal Mask (HC481A)
ARTG number: 97359
Sponsor: Fisher and Paykel Healthcare Ltd
Contact: 1800 121 542
Reason: A connector component used in a previous version of Fisher and Paykel CPAP masks may fail prematurely.
Letters are expected to be dispatched by the sponsor within two working days of the agreed date. Recall notices will appear in national newspapers from Monday 4 December 2006.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/news/product-recalls/cpap-masks-various-fisher-and-paykel

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