Pediatric Heart SJH, REF SJPH34K
This recall is currently active, issued October 26, 2023. It was issued by American Contract Systems, Inc..
- Company
- American Contract Systems, Inc.
- Recall Initiated
- September 1, 2023
- Posted
- October 26, 2023
- Recall Number
- Z-0176-2024
- Quantity
- 72 cases
- Firm Location
- Temple Terrace, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of FL, IA.
Lot / Code Info
UDI/DI 00191072167064, Lot Numbers: 975231
Root Cause
Process control
Action Taken
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.