BEUDAMED
    FDA Enforcement Class II Ongoing

    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

    Recall: Z-0180-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0180-2026
    Event ID
    97659
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 4, 2025
    Classification Date
    October 16, 2025
    Address
    1601 Se Gateway Dr Ste 120, Grimes, IA, 50111-5223, United States

    Description

    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

    Reason

    Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

    Code Info

    ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740; HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A; IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A; MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A; RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected

    Distribution

    US Nationwide distribution in the states of SD, IA, MN, WA, IL.

    Quantity

    32,433 total