Recall Z-1739-2014 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
| Date | Jun 9, 2014 (initiated May 1, 2014) |
| Status | Terminated |
| Reason | Container cap may contain foreign material- 0.60% - 0.80% Manganese |
| Root cause | Equipment maintenance |
| Action | Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. |
| Quantity | 12 bottles |
| Distribution | Distributed in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB Fresenius Medical Care North America, Jun 15, 2007 |