FDA-Device2023-11-01Class II
Robotics Pack, REF SJVO56B
American Contract Systems, Inc.
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.
Sold states
US Nationwide distribution in the states of FL, IA.
Affected count
112 cases
Manufactured in
7802 E Telecom Pkwy, N/A, Temple Terrace, FL, United States
Products
Robotics Pack, REF SJVO56B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2024Don't want to check this manually?
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