BEUDAMED
    FDA Enforcement Class II Terminated

    (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Recall: Z-2082-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2082-2021
    Event ID
    87998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 28, 2021
    Initiation Date
    April 28, 2021
    Classification Date
    July 16, 2021
    Termination Date
    August 8, 2022
    Address
    920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States

    Description

    (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    Reason

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Code Info

    (1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327

    Distribution

    US Distribution to: TX only

    Quantity

    (1) 20 cases (2) 30 cases