BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A

    Recall: Z-2986-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-2986-2024
    Event ID
    94583
    Classification
    Class II
    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
    September 18, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    September 6, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMHS, Pack Number DYNJ58876A

    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

    DYNDM1076A . Lot Number 19CBP748 ; DYNDM1076A . Lot Number 19DBH317 ; DYNDM1076A . Lot Number 19FBT944 ; DYNJ45158A . Lot Number 21KBK059 ; DYNJ45158A . Lot Number 21LBB289 ; DYNJ45158A . Lot Number 19ABZ159 ; DYNJ45158A . Lot Number 22DBS953 ; DYNJ45158A . Lot Number 22GBC899 ; DYNJ45158A . Lot Number 22GBE801 ; DYNJ45158A . Lot Number 19FBG969 ; DYNJ45158A . Lot Number 19FBM779 ; DYNJ45158A . Lot Number 19GBS210 ; DYNJ45158A . Lot Number 19HBS882 ; DYNJ45158A . Lot Number 19IBN282 ; DYNJ45158A . Lot Number 19JBB002 ; DYNJ45158A . Lot Number 23ABR333 ; DYNJ45158A . Lot Number 23CBK931 ; DYNJ45158A . Lot Number 23HBJ279 ; DYNJ45158A . Lot Number 23IBF733 ; DYNJ45158A . Lot Number 20HBR669 ; DYNJ45158A . Lot Number 20HBX586 ; DYNJ45158A . Lot Number 20LBZ104 ; DYNJ45158A . Lot Number 21EBP316 ; DYNJ51939. Lot Number 22CBA086 ; DYNJ51939. Lot Number 19ABY439 ; DYNJ51939. Lot Number 22OBI663 ; DYNJ51939. Lot Number 19HBH583 ; DYNJ51939. Lot Number 19IBU567 ; DYNJ51939. Lot Number 19JBW741 ; DYNJ51939. Lot Number 19JBX646 ; DYNJ51939. Lot Number 20FBT320 ; DYNJ51939. Lot Number 20LBF765 ; DYNJ51939. Lot Number 20LBK574 ; DYNJ56573. Lot Number 19ABN855 ; DYNJ56573. Lot Number 19CBF516 ; DYNJ56573. Lot Number 19EBQ417 ; DYNJ56573. Lot Number 19HBP237 ; DYNJ56573. Lot Number 19UBC593 ; DYNJ56573. Lot Number 19VBA937 ; DYNJ56573. Lot Number 19KBB135 ; DYNJ58876A . Lot Number 20HBW903 ; DYNJ58876A . Lot Number 20IBJ399 ; DYNJ58876A . Lot Number 20IBM299

    Distribution

    Worldwide distribution.