Medical device alerts archived in March 2018

Following our latest review of medical device alerts, we have archived the ones listed below.

Reference Title
MDA/2007/034 Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited.
MDA/2010/052 Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all manufacturers.
MDA/2012/031 Anaesthetic machines and associated devices, all manufacturers.
MDA/2013/002 Medical oxygen and medical air cylinders filled to 200 atmospheres - may cause damage to other devices.
MDA/2013/014 Oxoid antimicrobial susceptibility testing discs (AST) manufactured by Thermofisher Scientific.
MDA/2014/001 OPTEASE® retrievable vena cava filter, manufactured by Cordis Corporation. Lots with number 15960131 or below.
MDA/2015/005 CEM nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator. Manufactured by Integra LifeSciences.
MDA/2015/012 INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home and at point of care. Manufactured by Alere.
MDA/2015/019 All Birdie mobile hoists (lifters).
MDA/2015/023 Kent and Ascot baths with a transfer seat and shepherd’s crook / shower pole fitted. Manufactured by Care in Bathing Ltd.
MDA/2016/001 Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient.
[MDA/2016/003]https://mhra.filecamp.com/public/file/2rr1-n46ct0b6) All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted.
MDA/2016/004 Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results.
MDA/2016/005 Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment.
MDA/2016/006 CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion.
MDA/2016/008 Clinical chemistry tests: Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine (NAC).
MDA/2016/009R Home use blood glucose monitoring system: TRUEyou blood glucose test strips – risk of false low blood glucose results.
MDA/2016/010 RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test. Cassette – devices may give incorrect results that could lead to a missed diagnosis.
MDA/2016/011 Babytherm® 8004/8010 Infant Warmer, manufactured by Drägerwerk AG & Co – risk of fire.
MDA/2016/012 VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 and Oxylog 3000 plus ventilators – risk of rebreathing exhaled gases.
MDA/2016/013 SerenoCem Granules – risk of bone reabsorption around granules.
MDA/2016/014 Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results.
MDA/2016/015 Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia.
MDA/2016/017 AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm.
Published 7 March 2018