FDA Device recall Z-0179-2024
Robotics Pack, REF SSRO22D
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Robotics Pack, REF SSRO22D by American Contract Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0179-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-01 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Robotics Pack, REF SSRO22D
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.
Identifiers
| code_info | UDI/DI 00191072167705, Lot Numbers: 933231, 987231 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0179-2024%22
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