What's new in April 2011

New for April

• 28 Apr 2011 | Company-led drug recall: Technescan LyoMAA kits of five vials - Covidien UK Ltd - CLDA(11)A/05
  

  Covidien UK Ltd is recalling this product as a single glass particle was discovered in one vial.

• 28 Apr 2011 | Guidance for retailers, wholesalers, importers and manufacturers on the requirements of the Traditional Herbal Medicines Registration Scheme
  

  Manufactured herbal medicines placed on the UK market are required to have either a traditional herbal registration (THR) or a marketing authorisation (MA). This applies whether the product is marketed to consumers, herbal practitioners, retailers, or wholesalers.

• 26 Apr 2011 | Medical Device Alert: T34 syringe pump sets manufactured by CME (McKinley Medical UK) (MDA/2011/041)
  

  This Medical Device Alert has been issued due to a recall of extension sets manufactured before 1 January 2011 as there is potential for leakage at the female Luer (syringe) connector.

• 26 Apr 2011 | Weekly list of Field Safety Notices 18 – 22 April 2011
  

  FSNs from medical device manufacturers.

• 21 Apr 2011 | Press release: French regulator confirms non-toxicity of PIP breast implants
  

  The French medical device regulator has released the findings of comprehensive testing carried out on Poly Implant Prosthese (PIP) silicone breast implants following health concerns raised in 2010.

• 19 Apr 2011 | How to register your product under the Traditional Herbal Medicines Registration Scheme
  

  This section provides a comprehensive set of questions and answers on all apects of the Traditional Herbal Medicines Registration Scheme.

• 19 Apr 2011 | Medical Device Alert: Eclipse treatment planning system manufactured by Varian Medical Systems Inc (MDA/2011/040)
  

  This Medical Device Alert has been issued as when editing or changing the multi leaf collimator (MLC) using Eclipse, the dose plan may not recalculate automatically, as expected.

• 19 Apr 2011 | Medical Device Alert: Quickie Neon Swing-Away manual wheelchairs manufactured by Sunrise Medical (MDA/2011/039)
  

  This Medical Device Alert has been issued as the upper frame tubes that support the backrest can fail during use, leading to a fall for the user or the carer.

• 19 Apr 2011 | Medical Device Alert: Oxygen masks and face tent masks manufactured by Unomedical a/s (MDA/2011/038)
  

  This Medical Device Alert has been issued as degradation of the plastic within six to eight months of manufacture can result in a sticky substance appearing inside and/or outside the mask.

• 18 Apr 2011 | Weekly list of Field Safety Notices 11 – 15 April 2011
  

  FSNs from medical device manufacturers.