Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
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| Issued: 08 October 2008 at 14:30 |
Ref: MDA/2008/073
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Solus laryngeal mask airway manufactured by Intersurgical. Product code: 8002, lot no: 380009, NHS Supply Chain Number FDD749. |
>Page 2 |
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| Problem: Possibility of moulding defects in the device’s 15mm connector, which could cause it to break off during use. |
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| Action by: All staff who use, supply or purchase this device. |
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Action:
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Distributed to:
* via CE Bulletin |
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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. |
>Pages 2-3 |
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| Appendix: Manufacturer’s Urgent Field Safety Notice (in pdf only). |
>Pages 4-5 |
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Action deadlines for the Central Alerting System (CAS)
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Deadline (action underway): 29 October 2008
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Deadline (action complete): 19 November 2008
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