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| Issued: 07 February 2007 at 15:00 |
Ref: MDA/2007/014
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea. |
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| Problem: Plastic tabs incorporated into the re-usable CPAP mask connectors may break off when in use with the possibility of components entering the patient’s airways. The affected connectors are found in most Fisher and Paykel CPAP face, nasal and oral mask kits, and various tubing kits. Fisher and Paykel have now redesigned this connector (available since April 2006) and are recalling all face mask kits with the previous version; the recall notice and fax back form are appended to this alert (in pdf only). |
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| Action by: All those involved in the purchase and use of these devices. |
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Action:
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Distributed to:
* via CE Bulletin |
>Page 2 |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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| Appendix: Manufacturer's customer letter and recall fax back form (in pdf only). |
>Pages 4-7 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 23 February 2007
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Deadline (action complete): 16 March 2007
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MDA/2007/014 - Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea 
