其 他 安 全 警 示
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| The United Kingdom: Immediate Action Update: Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007 (English Only) |
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(Also supplied in various manufacturers’ drug administration kits, needle exchange packs, and other device packs.)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued alert because of a potential bacterial contamination of alcohol swabs which may lead to skin infection. This action update contains the following additional affected products:
1. Orbit Infusion Sets and Orbit Micro Infusion Sets supplied by ICU Medical Inc that include Triad Alcohol Preparation Pads.
2. PleurXTM Drainage Kits supplied by UK Medical Ltd / CareFusion that contain the sterile alcohol preparation pads manufactured by Triad Group.
3. Helixate® NexGen administration kits supplied by CSL Behring containing Con-Zellin alcohol swabs by Paul Hartmann AG.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON111498
Regarding the drug product, Helixate® NexGen is a human coagulation factor VIII and there is no record of registration in Hong Kong.
Ends/Friday, March 4, 2011
Issued at HKT 12:30
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