Recall Z-0500-2019 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical, Inc.
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
| Date | Oct 17, 2018 |
| Status | Terminated |
| Reason | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Root cause | Packaging process control |
| Action | NxStage initiated a recall on October 17, 2018 via " URGENT MEDICAL DEVICE REMOVAL" Recall Notice to its customers. The notice provided reason for recall, health risk, action to be taken. The customers were instructed to do the following: 1 Check all boxes in your Pureflow B solution inventory, separate them from your other inventory and do not use them. 2. Follow the instructions on the attached reply form or click on the following link to respond electronically, https://www.nxstage.com/rfprecalloct2018, to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service to arra |
| Quantity | 59100 |
| 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 |