Salter Labs 7600 Humidifier Recall Issued For Potentially Fatal Leaks

Federal health regulators indicate that Salter Labs humidifiers used in supplemental oxygen therapy may be defective and could lead to serious and potentially life-threatening situations. 

A 7600 Bubble Humidifier recall has been classified as a Class I medical device recall by the FDA, meaning that the agency believes the problems with a safety valve pose a high possibility of leading to a injury or death for individuals using the device.

The FDA made the determination earlier this week, but Salter Labs notified its customers of the humidifier recall last October. Despite the risks, there have been no reported injuries, deaths or actual known incidents discovered where the humidifiers failed.

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The Class I medical device recall designation was given to the recall because a manufacturing defect, discovered internally, could cause a humidifier lid to fail to pop off at the intended pressure. The defect could also cause a brass slug to fail to properly reseat when the lid does pop at the appropriate pressure, which could lead the device to leak.

The FDA says that if a patient is unconscious or asleep and fails to notice the problem, their airflow could be interrupted, resulting in injury or death. Conscious adult patients are at little risk, and there is also only a small risk when the device is used in a hospital setting with trained personnel and monitoring.

The Salter Labs 7600 Bubble Humidifier adds humidity to a supplemental oxygen supply. It is a single-use medical device.

The recall affects two lots of the Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve. The devices were sold between September 21 and October 17, 2011. They were sold under the following labels: Salter Labs, AdvaCare, Allcare Medical, Memorial Home Services, Therapy Support Inc., Mendo-Lake Home Respiratory Services, MedAssurance Inc. and Abundant Home Care. The recalled units have lot numbers of 091911 and 092611, and model numbers of 7600-0-50, E7600-0-50, NP7600-0-50. They were sold as part of special order patient kits.

Salter Labs is directing customers to examine their inventory to see if they have the recalled product. If so, the humidifiers should be removed and quarantined and a Recall Customer Reply form should be completed. Consumers with questions can call Salter Labs Customer Service at (800) 421-0024 or (800) 235-4203.


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