BEUDAMED
    FDA Enforcement Class III Terminated

    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

    Recall: Z-1942-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1942-2020
    Event ID
    85388
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    January 9, 2019
    Classification Date
    May 8, 2020
    Termination Date
    September 28, 2022
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

    Reason

    The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

    Code Info

    Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555

    Distribution

    57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI

    Quantity

    543 boxes were distributed; 10 ea per box.