The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Respironics SealFlex Single Port Ribbed Mask (Infant) manufactured by Engineered Medical Systems Inc. The affected reference number is 8-205508-00 and the affected lot number is 820550800110419.
According to the safety alert, the mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=64751&w=04172013&lang=eng
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 April 2013