Salter Labs has recalled 7600 of its Bubble Humidifiers, which are used with supplemental oxygen therapy, the U.S. Food and Drug Administration (FDA) just announced.
This is considered a Class I recall by the FDA, its most serious designation and involving a situation in which there is a reasonable probability that the use of, or exposure to, the recalled product will cause serious adverse health consequences or death.
A manufacturing defect was discovered in certain lots of the 7600 Bubble Humidifiers, in which the Salter Labs’ Bubble Humidifier lids fail to pop off at the intended pressure. When the pop-off occurs, the brass slug does not always reseat to the appropriate position. When the slug fails to reseat properly, the humidifier can leak. A humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences.
The 7600 Bubble Humidifier is used for supplemental oxygen therapy and is used to provide additional humidity to supplemental oxygen therapy. This product is a single-use device used in health care facilities and home health care. Model numbers include 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 bubble humidifiers. Lot numbers: 091911 and 092611.
Special order patient kits were sold under the following brand names:
• Salter Labs
• Allcare Medical
• Memorial Home Services
• Therapy Support Inc.
• Mendo-Lake Home Respiratory Services
• MedAssurance Inc.
• Abundant Home Care
Salter Labs contacted its direct customers with the defective Bubble Humidifiers to examine inventory of the recalled product and remove and quarantine all affected products.
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 to download the reporting form; by telephone 1.800.332.1088 to request a reporting form, or by fax to 1.800.FDA.0178.