BEUDAMED
    FDA Recall Terminated

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

    Recall: Z-0516-2019 · Initiated October 9, 2018

    Recall

    Recall Number
    Z-0516-2019
    Event Number
    81451
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 9, 2018
    Terminated
    August 5, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

    Reason

    Discolored powder has confirmed the presence of a foreign substance

    Action

    Fresenius issued on 10/9/18 via Certified Mail An Urgent Medical Device Recall Customer Notification to affected consignees asking the consignees to check their stock immediately. If they have any listed GranuFlo Dry Acid Concentrate lot. numbers discontinue use immediately and place the product in a secure, segregated area. The Urgent Medical Device Recall Customer Notification ask for the return of the affected lots and to contact Stericycle on instructions how to return the recalled lots. Contact Stericycle at 1-888-671-8851 for instructions on how to return the recalled product. This is EVENT# 10021.

    Distribution

    Distribution US nationwide and Mexico

    Quantity

    4752