Medical device alerts archived in March 2018

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

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

Updates to this page

Published 7 March 2018