BEUDAMED
    FDA Recall 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 · Initiated January 9, 2019

    Recall

    Recall Number
    Z-1942-2020
    Event Number
    85388
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    NKC
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    January 9, 2019
    Terminated
    September 28, 2022
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    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.

    Action

    The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm.

    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.