BEUDAMED
    FDA Recall Terminated

    Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step

    Recall: Z-0190-2012 · Initiated October 24, 2011

    Recall

    Recall Number
    Z-0190-2012
    Event Number
    60366
    Firm
    Isopure Corp
    FEI Number
    3013942511
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 24, 2011
    Posted
    November 16, 2011
    Terminated
    February 24, 2012
    Address
    141 Citizens Blvd, Simpsonville, KY, 40067-6548

    Description

    Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step

    Reason

    The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).

    Action

    Isopure sent a Product Recall Notice dated October 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue the use of any Step 2 chemical from the affected product, place any remaining chemical into the original box, seal it with tape, and segregate the product to prevent it from being placed back into stock. The firm will pick up the product for return on a call tag. Customers would receive replacement product for all affected cases of the Step 2 chemical the firm received. For questions call 502-722-1000.

    Distribution

    Nationwide Distribution including the following states: AL, AZ, CA, FL, GA, IN, KS, LA, MA, MO, MS, NC, NH, NJ, NM, NV, OH, OR, PA, SC, TN, TX, and VA

    Quantity

    91cs/12/4 oz plastic bottles