BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.

    Recall: Z-2228-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2228-2024
    Event ID
    94239
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2024
    Initiation Date
    March 14, 2024
    Classification Date
    June 28, 2024
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.

    Reason

    Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

    Code Info

    a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23DBK792, exp. 11/30/2027, UDI-DI each 10193489466812 and UDI-DI case-40193489466813. b. Pack #DYNJ56141A - lot numbers 23IBK595, exp. 1/31/2025, UDI-DI each-10193489555585 and UDI-DI case-40193489555586. c. Pack DYNJ62843A - lot numbers 24ABP043, exp. 12/31/2024, and 23IBM893, exp. 3/31/2025, UDI-DI each-10195327001766 and UDI-DI case-40195327001224. d. Pack #DYNJ63555C - lot numbers 24ALA613, exp. 3/31/2025; 23KLA748, 1/31/2025; 23KLA017, exp. 1/31/2025; 23JLA853, exp. 1/31/2025; 23JLA232. exp. 1/31/2025; 23ILB006, exp. 1/31/2025; 23ILA201, exp. 12/31/2024; and 23HLA429, exp. 12/31/2024; UDI-DI each-10193489816525 and UDI-DI case-40193489816526. e. Pack #DYNJ80649B - lot number 23JBG046, exp. 5/31/2026, UDI-DI each-10195327269944 and UDI-DI case-40195327269945.

    Distribution

    US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

    Quantity

    12,588 total sterile kits