BEUDAMED
    FDA Recall Terminated

    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

    Recall: Z-0657-2018 · Initiated October 17, 2017

    Recall

    Recall Number
    Z-0657-2018
    Event Number
    79197
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 17, 2017
    Posted
    February 20, 2018
    Terminated
    April 14, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

    Reason

    These finished good kits may contain the incorrect Springwire Guide (SWG).

    Action

    On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.

    Distribution

    Distribution US Nationwide

    Quantity

    5,926 total