BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM

    Recall: Z-1790-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1790-2019
    Event ID
    82865
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2019
    Initiation Date
    April 23, 2019
    Classification Date
    June 15, 2019
    Termination Date
    January 13, 2021
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM

    Reason

    Lidstock states the incorrect expiration date for the product

    Code Info

    Batch Code:13F17J0016, 13F17M0213

    Distribution

    Nationwide Foreign:

    Quantity

    190 units