BEUDAMED
    FDA Recall Terminated

    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

    Recall: Z-2393-2012 · Initiated August 15, 2012

    Recall

    Recall Number
    Z-2393-2012
    Event Number
    63105
    Firm
    Amsino Medical USA
    FEI Number
    1000151124
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 15, 2012
    Posted
    September 15, 2012
    Terminated
    August 13, 2013
    Address
    5209 Linbar Dr, Suite 640, Nashville, TN, 37211-1026

    Description

    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

    Reason

    One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.

    Action

    The firm, Amusa, notified their sole consignee of the mislabeled product via e-mail and telephone on August 15, 2012. An "URGENT-CLASS II MEDICAL DEVICE RECALL" letter dated August 22, 2012 was sent to the customer. The letter identified the product, problem, and actions to be taken by the customer. A Response Form was included for the customer to complete and return. Contact the firm at 615-521-2723 for questions regarding this recall.

    Distribution

    Distributed to one customer in Illinois.

    Quantity

    196,400 units