FDA Device

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

Hazard

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 You Should Do

Remedy

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 customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.

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Products

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Brand
NxStage Medical, Inc.
UPC
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

Units Affected

1243400 units

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