BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-0828-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0828-2024
    Event ID
    93656
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    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, 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

    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.

    Code Info

    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

    Distribution

    US Nationwide distribution.

    Quantity

    1020 units