Z-0828-2024 Class II Ongoing
FDA device recall Z-0828-2024 was initiated by American Contract Systems, Inc. on Nov 29, 2023 and is designated Class II. Reason for recall: 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 recall status is ongoing. Affected quantity: 1020 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 7, 2024
- Initiation Date
- Nov 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1020 units
Product Description
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
a) AGLP52L, UDI/DI 00191072144119, Lot Numbers: 933231, exp. 3/8/2024; 942231, exp. 2/27/2024; 947231, exp. 2/22/2024; 966231, exp. 2/3/2024; 980231, exp. 1/20/2024; 681221, exp. 11/15/2023; 707221, exp. 10/20/2023; b) HGOB98G, UDI/DI none, Lot Numbers: 667221, exp. 11/29/2023; 977231, exp. 1/23/2024; 952231, exp. 1/31/2024; 896231, exp. 1/31/2024; c) HHDV17, UDI/DI 00191072170125, Lot Numbers: 766221, exp. 8/22/2023; 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; 638221, exp. 12/28/2023; 946231, exp. 2/23/2024; d) MMGR44D, UDI/DI none, Lot Numbers: 709221, exp. 10/18/2023; 650221, exp. 12/16/2023; 891231, exp. 4/19/2024; e) MMJL16E, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 920231, exp. 3/21/2024; f) SMGY46, UDI/DI 00191072188458, Lot Numbers: 961231, exp. 2/8/2024; g) THLH71C, UDI/DI 00191072155108, Lot Numbers: 756221, exp. 9/1/2023; 708221, exp. 10/19/2023; h) UIHY16AA, UDI/DI none, Lot Numbers: 931231, exp. 3/10/2024; 896231, exp. 4/14/2024; i) WELP67C, UDI/DI 00191072173676, Lot Numbers: 751221, exp. 9/6/2023; 681221, exp. 9/13/2023; j) WELP67C-01, UDI/DI 00191072173676, Lot Numbers: 720221, exp. 9/21/2023; k) WELP67C-02, UDI/DI 00191072173676, Lot Numbers: 643221, exp. 9/13/2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0828-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026