Recall Z-2160-2024 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical Inc
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
| Date | Jun 20, 2024 (initiated May 14, 2024) |
| Status | Open, Classified |
| Reason | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL dated 5/14/24 was sent to customers. Action to be taken by Customers 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, separate them from your other inventory and do not use them. (Refer to Appendix B for how to locate lot number). 2. Follow the instructions on the attached reply form to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service (acuteorders@freseniusmedicalcare.com) to arrange for the return of all affected product. We understa |
| Quantity | 1316936 units |
| Distribution | US Nationwide distribution. |
| 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 |