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American Contract Systems, Inc. recalls Pediatric Heart SJH, REF SJPH34K
Recalled November 1, 2023 · FDA recall Z-0176-2024 · American Contract Systems
Hazard
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. · FDA Class II
Units
72 cases
Sold at
US Nationwide distribution in the states of FL, IA.
Description
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.
Product
Pediatric Heart SJH, REF SJPH34K
Manufacturer(s)
American Contract Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →