Pediatric Heart SJH, REF SJPH34K

Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

Code information: UDI/DI 00191072167064, Lot Numbers: 975231

Distribution pattern: US Nationwide distribution in the states of FL, IA.