Recall Z-0824-2021 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
| Date | Jan 11, 2021 (initiated Nov 7, 2020) |
| Status | Open, Classified |
| Reason | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE ALERT dated 11/7/20 was sent to customers. If you are in possession of the impacted product, it is recommended that all alternative options be explored prior to using this product. This includes determining if nonimpacted FMCRTG, LLC lots are available or using alternative suppliers of liquid acid product. This issue only impacts the list of lots provided- no other lots are affected. At this time, we are working with the FDA to determine appropriate next steps. Please note that we are currently experiencing a disruption in our supply, which may impact our ability to |
| Quantity | 27 drums |
| Distribution | US Nationwide distribution. |
| 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 |