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
FDA Recall Z-0190-2012 · Posted 2011-11-16
Advertisement
Recalling FirmIsopure Corp
Recall StatusTerminated
Product CodeKPO
Date Initiated2011-10-24
Date Terminated2012-02-24
Product Quantity91cs/12/4 oz plastic bottles
Reason for Recall
The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).
Firm 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.
Root Cause
Employee error
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement