Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits 의 안전성 경고

Safety alert

2011-08-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804.html

Fda class i recall: ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall concerning ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits. the vital signs hch is sold as part of the vital signs anesthesia breathing circuit. an hch is used to maintain moisture in the patient's airway during mechanical ventilation. the affected device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. clinical users have been directed to not use the anesthesia circuits containing the vital signs devices passive humidification device (hygroscopic condenser humidifier, or "hch"), or the stand alone hch device with the affected product item numbers and lot numbers, and to isolate all affected product. according to the local supplier, hong kong is not affected. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266542.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.