BEUDAMED
    FDA Recall Terminated

    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

    Recall: Z-2402-2020 · Initiated April 30, 2020

    Recall

    Recall Number
    Z-2402-2020
    Event Number
    85695
    Firm
    Diasol, Inc
    FEI Number
    3007137482
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 30, 2020
    Terminated
    May 28, 2024
    Address
    310 S 43rd Ave, Ste B, Phoenix, AZ, 85009-4606

    Description

    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

    Reason

    Incorrect labeling of dialysate concentration for hemodialysis.

    Action

    On 04/30/2020, the firm called customers informing them of the labeling error and instructed customers to: -Check if they have any remaining stock -Discontinue use of the specific lot -See if there have been any adverse events if used On 05/01/2020 the firm sent an "URGENT: MEDICAL DEVICE RECALL" to customers via certified mail informing them of the above and to contact customer service at (602) 442-7670 to arrange pickup of any stock of this lot number and replacement of a different lot number will be provided. For questions, contact Customer Service at (602) 442-7670.

    Distribution

    U.S.: CA O.U.S.:None

    Quantity

    212 Cases of 4 gallons each