The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Universal Flex2 Breathing Circuit [Part No.: DF4110-61; Lot no.: I063N], manufactured by King Systems Corporation.
The manufacturer received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 October 2013