BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

    Recall: Z-3059-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-3059-2024
    Event Number
    94583
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OIB
    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) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

    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.