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: 02 July 2007 at 14:00 |
Ref: MDA/2007/057
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Eliminator esophageal PET balloon dilator and pyloric/colonic PET balloon dilator manufactured by ConMed Corporation. |
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| Problem: Various labelling errors and inconsistencies have been identified, which can result in the use of an incorrect balloon size. |
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| Action by: Gastroenterologists, endoscopy staff, theatre staff and those responsible for the purchase and storage of these devices. |
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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. |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 10 July 2007
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Deadline (action complete): 07 August 2007
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