BEUDAMED
    FDA Recall Open, Classified

    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

    Recall: Z-0866-2024 · Initiated December 29, 2023

    Recall

    Recall Number
    Z-0866-2024
    Event Number
    93793
    Firm
    Aesculap Inc
    FEI Number
    2916714
    Product Code
    HCF
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 29, 2023
    Posted
    January 31, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

    Reason

    Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.

    Action

    On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.

    Quantity

    53