NxStage PureFlow B Solution - Premixed Dialysate for recall: Labeling Error
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Why was NxStage PureFlow B Solution - Premixed Dialysate for recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
- Product
- NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 1243400 units
- Distribution
- US nationwide distribution
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)