BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

    Recall: Z-2295-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2295-2023
    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. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

    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: DYNJ33638J, UPC Number: 019348956435. b. Model Number: DYNJRA1543, UPC Number: 019348921766. c. Model Number: DYNJRA1247, UPC Number: 019348950391. d. Model Number: DYNJ42367B, UPC Number: 019348921151. e. Model Number: DYNJRA1739, UPC Number: 019348926312. f. Model Number: DYNJ0134147D, UPC Number: 088994293734. g. Model Number: DYNJRA1220, UPC Number: 088827779503; Model Number: DYNJRA1571, UPC Number 019348926473. h. Model Number: DYNJRA1109A, UPC Number: 019348925132. i. Model Number: DYNJRA0656A, UPC Number: 088994222511; Model Number: DYNJRA1287A, UPC Number: 019348977309; Model Number: DYNJRA1604, UPC Number 019348929981. j. Model Number: DYNJRA0725, UPC Number: 019348926312. k. Model Number: DYNJ51107B, UPC Number: 019348981047. l. Model Number: DYNJRA1773, UPC Number: 019348986297. m. Model Number: PAIN1622A, UPC Number: 019348989169. n. Model Number: DYNJRA1635A, UPC Number: 019348936764.

    Distribution

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

    Quantity

    29,126 kits