Targeted safety letters for medical devices

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This new section of the site contains targeted safety letters (Dear Healthcare Professional letters) about medical devices which MHRA has sent to a limited number of identified healthcare professionals known to be affected by a particular issue.

Latest targeted safety letters for medical devices

December 2007 Baxter Healthcare Corporation - Duploject Easy Prep Iso Reconstitution device (109Kb)
Product codes: 1500949, 1500950, 1500951 - Lot no’s 07B069, 07B070, & 07B071
The MHRA has written to users of the Duploject Easy Prep Iso Reconstitution device who have yet to respond to Baxter.

2 August 2007 Field service corrective action: Sidhil Solite Safe-Side Full Length Mesh Side Rails (108Kb)
The MHRA has written to users of the Sidhil Solite Safe-Side Full Length Mesh Side Rails who have yet to complete a necessary update.

25 August 2006 m2000sp Instrument, List Number 9K14-01 System Software release 1.0 Part Number 50-148100 (251Kb)
The MHRA has written to Laboratory Managers to inform them of additional information provided by Abbott Molecular for the above device.

4 May 2006  Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer - Update (160Kb)
The MHRA has written to affected NHS Trusts in England with an update on a problem that may cause incorrect results in two diagnostic tests.

12 April 2006 Stratus CS STAT Analyser manufactured by Dade Behring. TestPak and DilPaks for Troponin I and D-Dimer (106Kb)
The MHRA has written to affected NHS Trusts in England informing them of a problem that may cause incorrect results in two diagnostic tests.


Page last modified: 03 March 2008