FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: Robotics Pack SAH, REF SAR530M
- Recall number
- Z-0174-2024
- Recalling firm
- American Contract Systems, Inc.
- Product
- Robotics Pack SAH, REF SAR530M
- Status
- Open, Classified
- Initiated
- 2023-09-01
- Posted
- 2023-10-26
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 96 cases
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Lot, serial or model codes
- UDI/DI00191072179678, Lot Numbers: 949231, 983231
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- Firm FEI
- 3003309947
- Firm city
- Temple Terrace
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28