The U.S. Food and Drug Administration (FDA) just announced that it 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 delivery to patients.
The FDA has classified this recall as a Class I, its most serious and representing 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. â€¨
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 can be accessed at on the FDA website at: http://www.fda.gov/Safety/Recalls/ucm266153.htm.
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 also 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. Customers are also directed to isolate all affected product.
All affected Hygroscopic Condenser Humidifier and Anesthesia Breathing Circuits with affected Hygroscopic Condenser Humidifiers are being replaced; customers may contact Vital Signs Customer Service, toll-free, at 1.800.932.0760 to arrange for the return and replacement of defective, recalled 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 Online: www.fda.gov/medwatch/report.htm; Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available online, and mail to the address on the pre-addressed form; or by fax to 1.800.FDA.0178.