BEUDAMED
    FDA Recall Terminated

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    Recall: Z-1852-2021 · Initiated April 21, 2021

    Recall

    Recall Number
    Z-1852-2021
    Event Number
    87795
    Firm
    Anodyne Surgical
    FEI Number
    1929756
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 21, 2021
    Terminated
    May 27, 2022
    Address
    804 Corporate Centre Dr, Saint Charles, MO, 63304-8684

    Description

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    Reason

    The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.

    Action

    The firm initiated the recall by email on 04/21/2021. The letter explained the issue and requested the return of the product.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.

    Quantity

    8452 units