BEUDAMED
    FDA Recall Open, Classified

    Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

    Recall: Z-2358-2019 · Initiated August 9, 2019

    Recall

    Recall Number
    Z-2358-2019
    Event Number
    83551
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    EYN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 9, 2019
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

    Reason

    Samples in the identified lot were found to have incomplete or open packaging seals.

    Action

    Consignees were notified via first class mail on August 9, 2019. The letter requested the following: 1. Immediately check your stock for item number DYNC2303 and the affected lot number, 19CAB954. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form as indicated. When we receive your completed destruction form your account will be issued a credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.

    Distribution

    US nationwide distribution

    Quantity

    11962 trays