Voluntary Worldwide Field Corrective Action of the Vital Signs Devices Hygroscopic Condenser Humidifier (HCH) / Anesthesia Breathing Circuit
Published: Aug 01, 2011
The Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier or “HCH”) may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient (hypoxia or hypoxemia). This device may be included in Vital Signs anesthesia circuits or sold separately. The affected units were manufactured between January 2011 and April 2011.
GE Healthcare initiated the field correction in April 2011, and began notifying customers with affected units through an Urgent Medical Device Correction Letter and a follow-up call to confirm receipt of the letter. Through these efforts, all customers were informed of the issue and provided with safety instructions. Customers 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 product item numbers and lot numbers listed below, isolate all affected product, contact Vital Signs Customer Service at 1-800-932-0760 to arrange for the return and replacement of product. All affected Hygroscopic Condenser Humidifier and Anesthesia Breathing Circuits with affected Hygroscopic Condenser Humidifiers are being replaced.
The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the volatile product will cause serious adverse health consequences or death.”
For additional information regarding this field correction, please contact Vital Signs Customer Service at 1-800-932-0760. Hours of Operation: 8:00 am EDT to 5:00 pm EDT, Monday through Friday.
GE HealthcareAnnette Busateri, +1 firstname.lastname@example.org