Recall Z-1132-2018 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical, Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
| Date | Nov 10, 2017 |
| Status | Terminated |
| Reason | Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use. |
| Root cause | Labeling design |
| Action | Customers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the cus |
| Quantity | 1243400 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 |