BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B; e. PICC TRAY, Model Number: DYNJ32988; f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A; g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E; h. TVS4700 CUSTOM PACK, Model Number: TVS4700;

    Recall: Z-2335-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2335-2023
    Event ID
    92399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    May 15, 2023
    Classification Date
    August 3, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B; e. PICC TRAY, Model Number: DYNJ32988; f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A; g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E; h. TVS4700 CUSTOM PACK, Model Number: TVS4700;

    Reason

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

    Code Info

    All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ63257C, UPC Number: 019348993830. b. Model Number: DYNJ906578C, UPC Number: 019532702355. c. Model Number: DYNJ9048708I, UPC Number: 019532707273. d. Model Number: PHS762887001B, UPC Number: 088994284931. e. Model Number: DYNJ32988, UPC Number: 088438924278. f. Model Number: DYNJ55361, UPC Number: 088994254669; Model Number: DYNJ55361A, UPC Number: 019532717352. g. Model Number: OBQ056E, UPC Number: 088827758937. h. Model Number: TVS4700, UPC Number: 081698202339.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

    Quantity

    6,340 kits