Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

Reason: The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Code information: REF 8-205508-00 Lot Number: 820550800110419.

Distribution pattern: Distributed in the states of PA, IN, NY, CO, and CA.