GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits
Recall Class: Class I
Date Recall Initiated: 4/29/11
Product: Vital Signs Passive Humidification Device (Hygroscopic Condenser Humidifier, or "HCH"). This product is manufactured by Vital Signs Devices, a GE Healthcare company.
A list of affected product codes and lot numbers is provided on the company's press release, available on FDA's website.
The affected products were manufactured between January 2011 and April 2011.
Use: 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.
GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha, Wisconsin 53188-1615
Reason for Recall: The HCH 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.
Public Contact: If you have questions about this recall, contact your local Vital Signs Account Manager, or contact Vital Signs Customer Service at 1-800-932-0760. Hours of Operation: 8:00 am EST to 5:00 pm EST, Monday through Friday.
FDA District: New Jersey
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 affected product item numbers and lot numbers, and to isolate all affected product.
Customers may 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.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.