BEUDAMED
    FDA Enforcement Class II Ongoing

    Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

    Recall: Z-2288-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2288-2020
    Event ID
    85645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    May 8, 2020
    Classification Date
    June 5, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

    Reason

    Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

    Code Info

    Lots: (Dist'd in US) 23F19A0260 23F19M0224 23F19E0120 23F19L0014 23F19B0184 (Dist'd OUS) 71F19M0710 71F18K1579 71F18F1429 71F18J2111 71F20A1078 71F20A1614 71F19E2019 71F19L0269 71F19L2068 71F19K1049 71F19K2042 71F19L0977 71F19M1319 71F20A0805 71F20A0812 71F20A0813 71F19J0604 71F19K1653 71F19K2501 71F19M0326 71F20A1819 71F20A2040 71F20A0044 71F19K2043 71F19L0359

    Distribution

    US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.

    Quantity

    109 eaches (US), 23,021 (OUS)