BEUDAMED
    FDA Recall Open, Classified

    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

    Recall: Z-0175-2026 · Initiated September 4, 2025

    Recall

    Recall Number
    Z-0175-2026
    Event Number
    97659
    Firm
    American Contract Systems Inc.
    FEI Number
    3007069947
    Product Code
    OES
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 4, 2025
    Posted
    October 16, 2025
    Address
    1601 Se Gateway Dr, Ste 120, Grimes, IA, 50111-5223

    Description

    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

    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.

    Action

    Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

    Distribution

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

    Quantity

    32,433 total