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| Issued: 22 March 2007 at 10:30 |
Ref: MDA/2007/028
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Reusable flexible laryngeal mask airway size 2.5 supplied by Intavent Orthofix Ltd. Model codes: 7125R and 7125DR. See appendix for serial numbers of affected devices (in pdf only). |
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| Problem: Risk of the tube kinking in the proximity of the connector, which could lead to the obstruction of airflow to the patient. The supplier has initiated a recall of specific serial numbers and has been unable to account for the serial numbers listed in the appendix. |
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| Action by: Anaesthetists, operating department practitioners, anaesthetic nurses, accident and emergency unit (A&E) staff, ambulance staff, sterile services department staff, supplies staff and all staff using anaesthetic equipment and associated devices. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of supplier 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: List of serial numbers of affected devices that have not been accounted for (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 29 March 2007
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Deadline (action complete): 23 April 2007
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