Posts Tagged ‘Class’


FDA Mediation Watch: Cardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit

Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected

May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall – Communication Error When Attached to EtCO2 or SpO2 Modules

May lead to termination of an infusion, which could result in serious injury or death. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall – Unit Goes Into Internal Backup Battery Sooner Than Expected

The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power. MedWatch Safety Alert RSS Feed

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