BEUDAMED
    FDA Enforcement Class II 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 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1852-2021
    Event ID
    87795
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Anodyne Surgical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 23, 2021
    Initiation Date
    April 21, 2021
    Classification Date
    June 11, 2021
    Termination Date
    May 27, 2022
    Address
    804 Corporate Centre Dr, Saint Charles, MO, 63304-8684, United States

    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.

    Code Info

    REF 7018, Lot Numbers: 201157-08 REF AS-7638, Lot Numbers: 210071-001, 210071-002 REF 7018NS, Lot Numbers: 210143-002 REF K20-3168, Lot Numbers:201108-005, 201108-017, 201108-018, 201154-007 REF 104910, Lot Numbers: 201144-002, 2010006-02, 210039-002, 210070-0001, 210080-01, 210127-001 REF CA7800, Lot Numbers: 201067-003, 201068-020 REF AX14784-BULK, Lot Numbers: 200580-006 REF RX2300NS, Lot Numbers: 200359-003 REF RX2300, Lot Numbers: 210142-002

    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