BEUDAMED
    FDA Recall Open, Classified

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

    Recall: Z-3107-2024 · Initiated June 27, 2024

    Recall

    Recall Number
    Z-3107-2024
    Event Number
    95128
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OEZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 27, 2024
    Posted
    September 11, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

    Reason

    Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

    Action

    Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Panama.

    Quantity

    1,646 units