· 25 February 2015 Recall of Vyclic Colour 3-way stopcock 2FL/1M: risk of sterility being affected
(Vygon) The paper side of the primary packaging could be punctured compromising sterility, manufacturer is recalling the devices. (MDA/2015/007)
Медичний виріб: триходовий кран Vyclic Colour виробництва Vygon (UK) Ltd
· 20 February 2015 Consent decree for medical devices supplied by Atrium Medical (Maquet)
(Atrium Medical subsidiary of Maquet) Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) consent decree from Maquet about its subsidiary Atrium Medical. (MDA/2015/006)
Медичний виріб: всі медичні вироби виробництва Atrium Medical (Maquet)
· 18 February 2015 CEM™ nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator - risk of burns
(Integra LifeSciences) Risk of burns to user if the blue COAG button on the CUSA Excel CEM nosecone sticks in the ‘activated’ position. (MDA/2015/005)
Медичний виріб: ультразвуковий аспіратор виробництва Integra LifeSciences
· 6 February 2015 Reissue: endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector
Reissued – ‘Problem’ section removed: (Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected. (MDA/2015/004R)
Медичний виріб: ендобронхіальні трубки виробництва Teleflex Medical
· 4 February 2015 Endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector
(Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected. (MDA/2015/004)
Медичний виріб: ендобронхіальні трубки виробництва Teleflex Medical