BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250

    Recall: Z-3040-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-3040-2024
    Event Number
    94583
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    PAD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 8, 2024
    Posted
    September 6, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Action

    Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

    Distribution

    Worldwide distribution.