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MHRA Field Safety Notice: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads

 

The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom has issued a Field Safety Notice on Spacelabs Healthcare¡¦s hook-up kits containing non-sterile alcohol prep pads.

Spacelabs Healthcare reported that non-sterile alcohol prep pads that contained in some of their hook-up kits, may have the presence of a bacterium, bacillus cereus, which could lead to life-threatening infection.

Spacelabs Healthcare suggests the users to stop using these alcohol prep pads immediately and dispose them according to hospital or clinic protocol.

For details, please refer to the MHRA website http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con134977.pdf

If you are in possession of the affected product, please contact your supplier for necessary actions.

 
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Last revision date: 23 November 2011