What's new in May 2011

New for May

• 27 May 2011 | Current key information on the combined oral contraceptive, Yasmin - May 2011
  

  Current information on the risks and benefits of Yasmin following a recent analysis of available epidemiological data.

• 27 May 2011 | Press release: Man fined £10,000 for illegal sale of lifestyle drugs
  

  A 27-year-old man from Uxbridge in northwest London was yesterday (26 May 2011) fined £10,000 at Southwark Crown Court for selling unlicensed medicines for erectile dysfunction.

• 27 May 2011 | Class 2 Drug Alert (Action within 48 hours): Intercell AG - Ixiaro Vaccine - EL (11)A/16
  

  Intercell AG is recalling one batch of Ixiaro, which is distributed in Novartis livery. This is because routine stability testing has shown that this batch may be less potent than expected and may not induce a full protective immune response in recipients.

• 26 May 2011 | Medical Device Alert: Enteral feeding pump: Applix Smart and Applix Vision Nutrition pumps. Manufactured by Fresenius Kabi (MDA/2011/058)
  

  This Medical Device Alert has been issued because there is a risk of under-delivery of enteral feed with the affected products.

• 26 May 2011 | Medical Device Alert: BLAKE® and J-VAC™ products. Manufactured by Ethicon (MDA/2011/057)
  

  The manufacturer issued a Field Safety Notice (FSN) for these devices on 24 March 2011. However the MHRA cannot be confident that the recall action has been effective and that users have received and acted on this information.
  

• 25 May 2011 | Medical Device Alert: Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24. Manufactured by Sorin CRM (MDA/2011/056)
  

  This Medical Device Alert has been issued because the manufacturer has published a Field Safety Notice following a programmer software anomaly that could lead to cardiac instability during surgery when a magnet is applied; or unnecessary explant due to inconsistent battery information.

• 23 May 2011 | Medical Device Alert: eXpert® DC Intraoral X-Ray systems manufactured by Gendex Dental Systems and supplied by KaVo Dental Ltd (MDA/2011/055)
  

  This Medical Device Alert has been issued because the manufacturer has not had sufficient confirmation from users that they have received and acted on the information contained in the Field Safety Notice (FSN) for this device (dated 12 January 2011).
  

• 20 May 2011 | Medical Device Alert: Level 1® Normothermic IV fluid administration sets for use with the Level 1 fast flow fluid warmer units. Manufactured by Smiths Medical (MDA/2011/054)
  

  This Medical Device Alert has been withdrawn and superseded by MDA/2011/076.

• 20 May 2011 | Medical Device Alert: Wound dressing. PremierPore VP Island Dressing. Manufactured by Shermond. Specific lot numbers (MDA/2011/053)
  

  This Medical Device Alert has been issued because the manufacturer has not had sufficient confirmation from users that they have received and acted on the information contained in the Field Safety Notice (FSN) for this device issued on 16 March 2011.

• 19 May 2011 | Medical Device Alert: Dermabond® (product code AHV12) and Dermabond™ Mini (product code AHVM12) - topical skin adhesive, manufactured by Ethicon Products, J&J Medical Ltd (MDA/2011/052)
  

  This Medical Device Alert has been issued as there have been reports that some units contained discoloured products in the vial and may have had prolonged setting times.