Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2018 – 28.04.2018

Опубліковано 03.05.2018 о 00:00




BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology

Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.

Medical device alert

Anaesthetics and 11 others


26 April 2018

·         Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision

Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.

Medical device alert

Orthopaedics and 1 others


20 April 2018

·         All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment

Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)

Medical device alert

Anaesthetics and 16 others


28 March 2018

·         Medical device alerts archived in March 2018

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

Medical device alert


6 March 2018

·         Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure

Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)

Medical device alert

Anaesthetics and 13 others


2 March 2018


If you have found a spelling error, please, notify us by selecting that text and pressing Ctrl+Enter.

Print button Версія для друку