Two recalls have been issued for the Teleflex Medical, MAQUET Servo Humidifier 163 for connector cracks and cracks in connector tubes. Some connector cracks were found when preparing patients for support with a ventilator. These cracks may lead to oxygen and other gases leaking from the ventilator and not delivering sufficient treatment to patients, potentially causing serious injury or death. Please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435607.htm Also, cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified. These cracks may cause oxygen and other gases to leak from the ventilator and prevent the device from delivering sufficient support to the patient. This may potentially cause serious injury or death. Please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435597.htm |