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| Issued: 17 June 2008 at 14:00 |
Ref: MDA/2008/041
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Electrosurgical single-use, sterile blades and needles. ‘Universal’ and ‘Ultraclean’ electrodes manufactured by ConMed. |
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| Problem: A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device (see appendix for list of relevant catalogue and lot numbers - in pdf only). |
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| Action by: Surgeons, theatre managers, operating theatre and supplies staff. |
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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 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: Catalogue and lot numbers of affected devices (in pdf only). |
>Page 4 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 01 July 2008
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Deadline (action complete): 17 July 2008
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MDA/2008/041 - Electrosurgical single-use, sterile blades and needles. ‘Universal’ and ‘Ultraclean’ electrodes manufactured by ConMed 
