Various Fisher and Paykel CPAP masks
Medical device recall for product correction
| Level: | Consumer | Class: | III |
|---|---|---|---|
| Reference: | RN-2006-0772 | Date agreed: | 24 November 2006 |
| Product: | Various Fisher and Paykel CPAP masks (see below) | ||
| ARTG number: | 97359 | ||
| Model: |
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| Sponsor: | Fisher and Paykel Healthcare Ltd | ||
| Phone: | 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.