American Contract Systems, Inc. 2023-11-01 Health serious FDA
Health · FDA · Recall #FDA-Z-0174-2024
Robotics Pack SAH, REF SAR530M Recall
Issued November 1, 2023 · American Contract Systems, Inc.
In November 2023, American Contract Systems, Inc. recalled the Robotics Pack SAH, REF SAR530M, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Robotics Pack SAH, REF SAR530M right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact American Contract Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- American Contract Systems, Inc.
- Category
- Health
- Recall date
- November 1, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of FL, IA.
- Recall number
- FDA-Z-0174-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- American Contract Systems, Inc. has 10 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.