Class 3 Device Recall Step 2, 300022000 GPD (Sodium Hydroxide 2.0N)

• Date Initiated by Firm: October 24, 2011
• Date Posted: November 16, 2011
• Recall Status: Terminated on February 24, 2012
• Recall Number: Z-0190-2012
• Recall Event ID: 60366
• 510(K)Number: K041163
• Product Classification: Subsystem, water purification - Product Code KPO
• Product: 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
• Code Information: Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.
• Recalling Firm/ Manufacturer: Isopure Corp; 141 Citizens Blvd; Simpsonville KY 40067-6548
• For Additional Information Contact: 502-722-1000
• Manufacturer Reason for Recall: The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).
• FDA Determined Cause: Employee error
• 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.
• Quantity in Commerce: 91cs/12/4 oz plastic bottles
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPO and Original Applicant = ISOPURE CORP.