Recall Z-2110-2018 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Renal Therapies Group, LLC
NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid conc
| Date | May 2, 2018 |
| Status | Terminated |
| Reason | The bottles are mislabeled with an incorrect part number. |
| Root cause | Employee error |
| Action | Phone calls and Urgent Medical Device Recall notification letters were issued on 5/2/18. Customers were instructed to do the following: Immediately examine your stock to determine whether you have any NaturaLyte Liquid Acid from the lot listed above. If any products of this lot is found, discontinue use immediately. Place all units in a secure, segregated area. Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product and arrange for replacement product. Promptly fill out and return the attached reply form. |
| Quantity | 1060 cases (4240 bottles) |
| Distribution | Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES Fresenius Medical Care North America, Mar 29, 2007 |