BEUDAMED
    FDA Recall Open, Classified

    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

    Recall: Z-1411-2021 · Initiated March 5, 2021

    Recall

    Recall Number
    Z-1411-2021
    Event Number
    87542
    FEI Number
    2647580
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    March 5, 2021
    Address
    Covidien 201 Sabanetas Industrial Park Building 911-67, Ponce, PR, 00716

    Description

    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

    Reason

    Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

    Action

    On 3/10/2021, Medtronic issued an Urgent Medical Device Recall notices to customers. All consignees were notified by letter delivered via Federal Express and/or certified mail. The letter informs customers of the recall of specific item codes and production lots of Covidien Surgiwand" II Suction and Irrigation Device following reports from customers of foreign particles in the device tubing.

    Distribution

    Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    59,828 devices