BEUDAMED
    FDA Recall Open, Classified

    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837

    Recall: Z-0646-2025 · Initiated October 9, 2024

    Recall

    Recall Number
    Z-0646-2025
    Event Number
    95621
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OJF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 9, 2024
    Posted
    December 5, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837

    Reason

    Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

    Action

    Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

    Distribution

    US Nationwide distribution.

    Quantity

    3452 units