BEUDAMED
    FDA Recall Terminated

    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

    Recall: Z-2183-2013 · Initiated August 16, 2013

    Recall

    Recall Number
    Z-2183-2013
    Event Number
    65978
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 16, 2013
    Posted
    September 10, 2013
    Terminated
    October 21, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113

    Description

    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

    Reason

    Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

    Action

    Covidien sent an Urgent Medical Device Recall letter dated August 16, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested that customers immediately quarantine and discontinue use of the affected products, return any affected product by following the instructions provided in the letter, and complete and return the Recalled Product Return Form to Covidien. The letter states that if the affected products have been distributed, assure that all customers are notified and affected product is removed from the distribution channel as well as from customer stock. Questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service, Monday through Friday, 8am- 6:30pm ET, at (800) 962-9888, option 1, and then option 2. Firm issued Press on 8/19/13

    Distribution

    Worldwide Distribution - USA Nationwide and the country of Bermuda

    Quantity

    Unknown