Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure
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
AUDIENCE: Home Care, Consumers
ISSUE: FDA notified healthcare professionals of a Class I recall of Salter Labs 7600 Bubble Humidifier. A manufacturing defect was discovered in certain lots of the 7600 Bubble Humidifiers, where the humidifier lids failed 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.
BACKGROUND: The 7600 Bubble Humidifier is used for supplemental oxygen therapy. The humidifier 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.
RECOMMENDATION: Salter Labs contacted its direct customers on October 21, 2011, the date the recall was initiated, to inform them of the recall. Salter Labs instructed consumers who have the affected bubble humidifiers to examine its 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
- 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
[02/13/2012 - Recall Notice - FDA]