Аналіз інформації за період 01.07.2015 – 31.07.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 07.09.2015 о 00:00



·                     23 July 2015 Steel cannula infusion sets – risk of needle breaking in use

(Unomedical a/s) May cause leakage of medication and require surgical intervention to remove the needle (MDA/2015/027)


·                     21 July 2015 Haemodialysis CRIT-LINE® blood chamber with product code CL10021021 – recall due to risk of blood loss

(Fresenius USA Manufacturing Inc. / Hemametrics) Recall of all lots due to risk of blood loss caused by leakage at the blood chamber connection (MDA/2015/026)


·                     6 July 2015 TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer – risk of serious burn

(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)


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