Medical Device Alerts issued in December 2019

Alerts were issued about Arrow EZ-IO intraosseous vascular access needle sets, Medicina IV Luer Slip syringes, and Spectra Optia apheresis systems.

In this monthly update, we highlight selected Medical Device Alerts and notices that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury. Issued 19 December 2019. Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043). Issued 11 December 2019. Manufactured by Medicina – syringes incorrectly packaged with a needle could mean they are not sterile and could cause a needlestick injury.

Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041). Issued 4 December 2019. Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.

Article citation: Drug Safety Update volume 13, issue 6: January 2020: 5.

Published 27 January 2020