The U.S. Food and Drug Administration announced in a news release Friday that Vital Signs Devices, a GE Healthcare Company, has initiated what the company is calling a “voluntary worldwide field correction” of a medical humidifier due to a defect that may cause insufficient oxygen to reach a patient.
The field correction, which the FDA has classified as a Class I recall, is of the Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier) stems from a possible occlusion that can impede the proper flow of oxygen or medicinal gases to a patient. The unit may be sold individually or included with Vital Signs anesthesia circuits. The humidifiers affected by the recall were sold between January 2011 and April 2011.
GE Healthcare began the recall in April, notifying customers through an Urgent Medical Device Correction letter and making follow-up calls to confirm that the letter was received. Customers were told of the problem, given safety instructions, and told not to use anesthesia circuits containing the defective humidifier or the stand-alone device for specific product item and lot numbers. Customers were instructed to contact Vitals Signs Customer Service to arrange the return and replacement of the products. All affected humidifiers and anesthesia breathing circuits with affected humidifiers are being replaced.
The FDA’s Class I recall classification places the field correction in a group of recalls considered “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.”
As a Los Angeles personal injury lawyer, I hope that no patients have been harmed through the use of the defective humidifiers.