BEUDAMED
    FDA Recall Open, Classified

    VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS

    Recall: Z-1463-2023 · Initiated March 22, 2023

    Recall

    Recall Number
    Z-1463-2023
    Event Number
    92004
    FEI Number
    1282497
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 22, 2023
    Posted
    April 26, 2023
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS

    Reason

    There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning used cannulas. Utilization of appropriate personal protective equipment is advisable during decontamination of the device. " Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) " Medtronic Technical Services at 1-800-962-9888, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

    Distribution

    Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.

    Quantity

    145 units