Аналіз інформації за період 01.08.2015 – 31.08.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 07.09.2015 о 00:00



·                     26 August 2015 Sterile electrosurgical forceps and electrodes – Some devices may not be sterile

(Zethon Limited and Ross Electro Medical Limited) Recall of specific batches (MDA/2015/033)


·                     25 August 2015 Charging base for surgical hair clippers – recall of specific lots due to risk of fire

(Medline Industries) Risk of fire in oxygen-rich environment if defective charging base overheats (MDA/2015/032)


·                     18 August 2015 Accu-Chek mobile meter and Accu-Chek mobile test cassette – risk of falsely high readings if testing procedure is not followed

(Roche Diabetes Care) Home-use blood glucose monitoring system – if patients do not follow specific testing procedure they may take insulin when they don’t need it (MDA/2015/031)


·                     5 August 2015 Shiley™ neonatal and paediatric tracheostomy tubes – recall of specific affected products

(Medtronic – previously Covidien) Shiley NEF/NCF/PEF/PCF/PELF/PLCF tracheostomy tubes are being recalled, as some patients experience breathing difficulties when changing to these earlier models of tube from current tubes (MDA/2015/030)


·                     4 August 2015 All Accu-Chek® Insight insulin pumps – risk of hyperglycaemia from rapid pump battery depletion or unexpected shut down

(Roche Diabetes Care) Advice from manufacturer to users about the correct battery specification and appropriate pump settings (MDA/2015/029)


·                     4 August 2015 Automatically retracting safety syringes including insulin syringes by Medicina Ltd – recall

(Medicina Ltd) Risk of needle stick injury as they may not automatically retract and the shelf life stated on the devices is incorrect, compromising its sterility (MDA/2015/028)



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