Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Enforcement
- Recall Number
- Z-0821-2024
- Event ID
- 93656
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- February 7, 2024
- Initiation Date
- November 29, 2023
- Classification Date
- January 26, 2024
- Address
- 7802 E Telecom Pkwy, Temple Terrace, FL, 33637-0928, United States
Description
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
AHBP12A, UDI/DI 00191072188229, Lot Numbers: 963231, exp. 1/21/2024; 940231, exp. 1/21/2024; 996231, exp. 2/28/2023
US Nationwide distribution.
95 units