Robotics Pack SAH, REF SAR530M
Recall
- Recall Number
- Z-0174-2024
- Event Number
- 93086
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3003309947
- Product Code
- FDE
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 1, 2023
- Posted
- October 26, 2023
- Address
- 7802 E Telecom Pkwy, Temple Terrace, FL, 33637-0928
Description
Robotics Pack SAH, REF SAR530M
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.
Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.
US Nationwide distribution in the states of FL, IA.
96 cases