FDA Enforcement
Class II
Ongoing
Pediatric Urology Wolson Pack, REF BPPU55A
Recall: Z-0181-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0181-2024
- Event ID
- 93086
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 1, 2023
- Initiation Date
- September 1, 2023
- Classification Date
- October 26, 2023
- Address
- 7802 E Telecom Pkwy, N/A, Temple Terrace, FL, 33637-0928, United States
Description
Pediatric Urology Wolson Pack, REF BPPU55A
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.
Code Info
UDI/DI 00191072187949, Lot Numbers: 923231, 977231
Distribution
US Nationwide distribution in the states of FL, IA.
Quantity
448 cases