FDA recall Z-0175-2024

American Contract Systems, Inc. · Class II · device

Product

CVS PCSU SJH, REF SJCV48J

Reason for recall

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.

Distribution

US Nationwide distribution in the states of FL, IA.

Key facts

Status
Ongoing
Initiation date
2023-09-01
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Temple Terrace, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2024