BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A

    Recall: Z-2443-2024 · Reported August 14, 2024

    Enforcement

    Recall Number
    Z-2443-2024
    Event ID
    94580
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 14, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    August 8, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A

    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.

    Code Info

    DYNJ59089 , Lot Number 23IBF074 ; DYNJRA1221A , Lot Number 20IDB255 ; DYNJRA1221A , Lot Number 22BDA978 ; DYNJRA1221A , Lot Number 22KDA950 ; DYNJRA1221A , Lot Number 22LDA146 ; DYNJRA1221A , Lot Number 23ADB422 ; DYNJRA1221A , Lot Number 23BDB453 ; DYNJRA1221A , Lot Number 23IDA424 ; DYNJRA1221A , Lot Number 23JDB010

    Distribution

    Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.

    Quantity

    1,679,067 units in total