Recall Z-1612-2012 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
| Date | May 15, 2012 (initiated Mar 16, 2012) |
| Status | Terminated |
| Reason | Sodium content does not meet product requirements |
| Root cause | Process control |
| Action | Fresenius Medical Care North America sent an "URGENT PRODUCT RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine whether they have any affected product. A fax back form was included for customers to complete and return. Contact FMCNA Customer Service Team at 1-800-323-5188 for questions regarding this notice. |
| Quantity | 154 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL Solution Technologies, May 26, 1998 |