BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    Recall: Z-2256-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2256-2017
    Event ID
    76937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    March 20, 2017
    Classification Date
    June 6, 2017
    Termination Date
    December 18, 2018
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    Reason

    Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

    Code Info

    510K # K061289; Material numbers: EU-04041-HPMSB, EU-04052-HPMSB, EU-05041-HPMSB, and EU-05052-HPMSB.

    Distribution

    Nationwide Distribution

    Quantity

    unknown-firm reports total devices distributed 43,394 eaches