BEUDAMED
    FDA Recall Terminated

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    Recall: Z-1808-2015 · Initiated February 9, 2015

    Recall

    Recall Number
    Z-1808-2015
    Event Number
    70974
    Firm
    MRP, LLC dba AMUSA
    FEI Number
    1000151124
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 9, 2015
    Posted
    June 15, 2015
    Terminated
    June 22, 2015
    Address
    5209 Linbar Dr, Ste 640, Nashville, TN, 37211-1026

    Description

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    Reason

    Incorrect labeling of the expiration date

    Action

    The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: [email protected].

    Distribution

    US distribution to CA only.

    Quantity

    1,080 units (3 cases)