Robotics Pack, REF SJVO56B
Published November 1, 2023 · Recall initiated: September 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems, Inc.
- Distributor
- US Nationwide distribution in the states of FL, IA.
- Lot
- UDI/DI 00191072122339, Lot Numbers: 965231
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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