The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning components of MAQUET Servo Humidifier 163 [Model number: 01-06-8125-8; Catalogue number: XKC01-06-8125-8; Batch Numbers: 201321, 201323, and 201324], manufactured by Arrow International Inc.
The recall was initiated because of connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
For details, please refer to the following FDA website:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 February 2015