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Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

SunMed Holdings, LLC is recalling this product due to a manufacturing issue where the B/V filter was assembled onto the patient port instead of the exhalation port. This incorrect configuration may result in a delay in therapy during emergency use.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact SunMed Holdings, LLC at 1-800-433-2797.