BEUDAMED
    FDA Recall Terminated

    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

    Recall: Z-1741-2017 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-1741-2017
    Event Number
    76606
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    HMP
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 3, 2017
    Posted
    March 27, 2017
    Terminated
    October 7, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

    Reason

    Product sterility is compromised due to breach of sterile barrier

    Action

    Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.

    Distribution

    Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.

    Quantity

    1659500