American Contract Systems recalls Robotics Pack REF SJVO56B due to possible loss of function or drug efficacy from improper sterilization. Affected units have specific lot numbers and UDI/DI codes.
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.
American Contract Systems is recalling Robotics Pack REF SJVO56B because sterilization errors may cause components to lose function or reduce drug effectiveness. This could affect medical use of the product.
The components were exposed to higher temperatures and EO gas during sterilization than approved. This could cause the components to stop working properly or reduce the effectiveness of drugs they deliver.
Healthcare professionals using the Robotics Pack REF SJVO56B for medical procedures are most at risk. Patients receiving treatments with this product may be affected if the components lose efficacy.
Check for the product code REF SJVO56B and UDI/DI 00191:1072122339. Lot numbers 965231 are affected.
Verify the product code REF SJVO56B and UDI/DI 00191072122339 to confirm if your unit is affected.
The components were exposed to higher temperatures and EO gas during sterilization than approved, which may cause loss of function or reduced drug efficacy.
Check the product code and UDI/DI to see if it matches the recalled units. No specific action is required beyond verification.
The recall addresses potential loss of function or reduced drug effectiveness, not immediate safety hazards like injury or fire.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0178-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0178-2024 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
