A51

HealthCare Alerts

Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017)
Recall - Cook Medical Transseptal Needle Due to Risk of Detached Plastic Fragments
enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer (MDA/2019/016)
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers
Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity
Field Safety Notice: 4 to 8 March 2019
Medical Advisory (ICSA-18-067-01) Siemens SIPROTEC 4, SIPROTEC Compact, DIGSI 4, and EN100 Ethernet Module (Update C)
Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers
UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication
Recall - AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

Events

Trojan horse