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Bubble Humidifier Recalled Due to Manufacturing Defect Possibly Resulting in Hypoxemia


The 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.

 

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. Special order patient kits were sold under the following brand names: Salter Labs, AdvaCare, Allcare Medical, Memorial Home Services, Therapy Support Inc., Mendo-Lake Home Respiratory Services, MedAssurance Inc. and Abundant Home Care.

 

Consumers who have the affected bubble humidifiers should remove and quarantine all affected products.

 

See the FDA Announcement

 

 

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