Recall Z-1707-2019 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical, Inc.
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
| Date | Apr 11, 2019 |
| Status | Terminated |
| Reason | Certain lots were mislabeled with incorrect product number. |
| Root cause | Labeling mix-ups |
| Action | On April 11, 2019, NxStage Medical Inc. issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following actions: 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots listed in the table below, separate them from your other inventory and do not use them. Refer to Appendix A for pictures to assist in locating part or SKU and lot number of your Pureflow B solution inventory. 2. Promptly complete and return the online response form at the link ww |
| Quantity | 3,940 units |
| Distribution | US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc., Dec 22, 2005 |