Recall Z-0190-2012 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Isopure Corp
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
| Date | Nov 16, 2011 (initiated Oct 24, 2011) |
| Status | Terminated |
| Reason | The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl). |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES Isopure, Corp., Oct 7, 2004 |