American Contract Systems, Inc. recalls Sub Q Recorder Pack, REF BPRC87A
Recalled Product
Sub Q Recorder Pack, REF BPRC87A
Hazard / Issue
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.
Issued by
FDA
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