ISSUE: FDA notified healthcare professionals of a Class I recall of GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits. 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.
BACKGROUND: 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 products were manufactured between January 2011 and April 2011. A list of affected product codes and lot numbers is provided on the company press release.
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the Recall Notice and Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266580.htm