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: 13 August 2007 at 14:30 |
Ref: MDA/2007/061
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Oxygen humidifier: - Hudson RCI® large volume nebuliser, product code 41770, NHS Supply Chain Code FDE 069. Lot numbers consisting of 10 numbers beginning: 50069/….., 52069/….., 01079/….., 06079/….., 16079/….., 17079/….. 17079R/…., 18079/….. Manufactured by Teleflex Medical. |
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| Problem: There is the potential for lower than required oxygen concentration to be delivered due to a manufacturing fault. The manufacturer has recalled the above devices. (See Appendix - in pdf only). |
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| Action by: Medical and nursing staff. Supplies departments. |
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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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| Appendix: Manufacturers recall letter and faxback form (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 28 August 2007
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Deadline (action complete): 11 September 2007
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