Recall Z-2686-2014 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product 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 | Sep 23, 2014 (initiated Jun 23, 2014) |
| Status | Terminated |
| Reason | Product was held at temperature above the labeled recommended storage temperature |
| Root cause | Storage |
| Action | Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and faxback form Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate. If customers have the affected product, they are instructed to contact FMC-RTG Customer Service to have the product replaced. A revised/clarification letter dated 7/10/14 issued to state only products from the identified lots that were delivered by |
| Quantity | 72 cases |
| Distribution | Distributed in Texas. |
| 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 |