Recall Z-1750-2015
ResMed Ltd. · initiated May 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Codes / lots: Serial No. 22141256746 22141256747 22141256749 22141256750 22141256752 22141256753 22141256754 22141256755 22141256756 22141256757 22141256758 22141256759 22141256760 22141256761 22141256762 22141256763 22141256764 22141256765 22141256766 22141256767 22141256768 22141256770 22141256771 22141256773 22141256774 22141256776 22141256777 22141256778 22141256780 22141256781 22141256782 22141256783 22141256784 22141256785 22141256786 22141256787 22141256788 22141256789 22141256790 22141256792 22141256793 22141256795 22141256796 22141256797 22141256798 22141256800 22141256802 22141256803 22141256804 22141256805 22141256808 22141256809 22141256810 22141256811 22141256812 22141256813 22141269796 22141269797 22141269798 22141269800 22141269801 22141269802 22141269803 22141269804 22141269805 22141269806 22141269807 22141269808 22141269809 22141269810 22141269811 22141269812 22141269813 22141269814 22141269815 22141269817 22141269818 22141269819 22141269820 22141269821 22141269822 22141269823 22141269824 22141269825 22141269826 22141269827 22141269828 22141269829 22141269830 22141269831 22141269832 22141269833 22141269834 22141269835 22141269836 22141269837 22141269838 22141269841 22141269842…
Reason for recall
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.
FDA-determined cause: Use error
Action taken
A customer notification letter dated 5/5/15 will be sent to customers that the Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. The letter provides the customers with the hazards involved and the actions to be taken. Customers are instructed to ensure alarms are appropriately set up for ventilator dependent patients. Customers with questions are instructed to contact Larissa D'Andrea at (858) 836-6837 or email larissa.d'andrea@resmed.com.
Details
- Recall number
- Z-1750-2015
- Initiated
- May 5, 2015
- Posted by FDA
- June 10, 2015
- Terminated
- April 7, 2016
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Quantity
- 1519 units
- Distribution
- Worldwide distribution. US nationwide, Uruguay and Canada.
- Recalling firm
- ResMed Ltd.