BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM

    Recall: Z-2025-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-2025-2018
    Event ID
    79890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    April 11, 2018
    Classification Date
    May 30, 2018
    Termination Date
    May 15, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM

    Reason

    Product sterility may be compromised due to unsealed packaging.

    Code Info

    Lot Numbers: Product code: PR-44041-BAS: 13F17F0101 PR-44052-BAS: 13F17F0103 13F17K0128 PR-44063-BAS: 13F17F0104 13F17K0129 PR-45041-BAS: 13F17F0105 13F17K0241 PR-45052-BAS: 13F17F0106 13F17K0236 PR-45063-BAS: 13F17J0203 13F17K0471 PR-45541-BAS: 13F17F0107 PR-45541-HPHNL: 13F17A0165 13F17D0327 13F17G0008 13F17H0416 13F17H0572 13F17K0238 13F17L0049 PR-45541-HPHNM: 13F17B0174 13F17C0188 13F17E0738 13F17G0006 PR-45552-BAS: 13F17F0108 13F17K0237 PR-45552-HPHNL: 13F17C0467 13F17E0017 13F17E0758 13F17F0523 PR-45552-HPHNM: 13F17B0178 13F17C0469 13F17E0120 13F17G0412 13F17H0393 13F17J0172 13F17L0335 PR-45563-BAS: 13F17F0109 PR-45563-HPHNL: 13F17C0354 13F17D0341 13F17J0402 PR-45563-HPHNM: 13F17L0688

    Distribution

    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

    Quantity

    416,055 total products