BEUDAMED
    FDA Recall Open, Classified

    Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

    Recall: Z-1731-2024 · Initiated January 9, 2024

    Recall

    Recall Number
    Z-1731-2024
    Event Number
    93883
    Firm
    Covidien
    FEI Number
    2936999
    Product Code
    MUD
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    January 9, 2024
    Posted
    April 30, 2024
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

    Reason

    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

    Action

    On January 9, 2024 Medtronic (parent company of Covidien) issued a Urgent Medical Device Recall notification via UPS. Medtronic asked consignees to take the following action: 1. Quarantine and stop using all product from the affected lots of INVOS" Reusable Sensor Cables PMAC71RSC and PMAC71RIC. " See attachment A for guidance on how to identify affected devices via cable box packaging or cable hang tag. 2. Complete and return Customer Confirmation Form. Complete and return the enclosed Customer Confirmation Form even if you do not have any affected lots remaining. 3. Reach out to Medtronic to obtain RGA # /Returned Goods Authorization number. " Your Medtronic Representative / Medtronic Customer Service at [email protected] can assist in initiating product return as necessary. 4. Return all product from the affected lots in your possession to Medtronic as described on the Customer Confirmation Form. 5. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.

    Distribution

    US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom

    Quantity

    1122 units