FDA issues Class I recall of GE's humidification devices
The FDA has issued a Class I recall of GE Healthcare Vital Signs Hydroscopic Condenser Humidifier Passive Humidification devices (HCH), which are used with the Vital Signs Anesthesia Breathing Circuits.
The Vital Signs HCH was sold as part of the Vital Signs anesthesia breathing circuit, according to the FDA, and is used to maintain moisture in patients’ airways during mechanical ventilation. The products affected were manufactured between January and April of this year.
Affected product codes and lot numbers can be found here.
Customers have been directed to stop using anesthesia circuits containing the device, and GE initiated a field correction in April, notifying customers with affected units through an urgent message and follow-up call to confirm receipt. The FDA encourages healthcare professionals to report adverse events or side effects relating to the use of the product.
The Vital Signs HCH was sold as part of the Vital Signs anesthesia breathing circuit, according to the FDA, and is used to maintain moisture in patients’ airways during mechanical ventilation. The products affected were manufactured between January and April of this year.
Affected product codes and lot numbers can be found here.
Customers have been directed to stop using anesthesia circuits containing the device, and GE initiated a field correction in April, notifying customers with affected units through an urgent message and follow-up call to confirm receipt. The FDA encourages healthcare professionals to report adverse events or side effects relating to the use of the product.