BEUDAMED
    FDA Recall Terminated

    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

    Recall: Z-0756-2017 · Initiated October 14, 2016

    Recall

    Recall Number
    Z-0756-2017
    Event Number
    75481
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    FMH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 14, 2016
    Terminated
    August 8, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

    Reason

    Sterility of the outer surface of the container compromised due to packaging defect.

    Action

    Covidien initiated recall by letter on October 14, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Accounts requested to completed Recalled Product Return From to obtain an RGA. Questions: Contact your Medtronic representative or Customer Service at (800) 882-5878.

    Distribution

    Nationwide Foreign: Japan

    Quantity

    5,187,100 Units