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

Is my product affected?

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

• UPC 00842289101258
• UPC 00842289101265

Check against the official notice below — it lists the full affected range.

What happened

NxStage Medical, Inc. is recalling approximately 1.24 million units of NxStage PureFlow B Solution, a premixed dialysate used with the NxStage System One for hemodialysis treatment. The product was distributed nationwide across multiple lot codes. The recall was initiated because using different fluid formulations of the product at the same time during treatment may cause patient health risks. The original product labeling did not include warnings against mixing different dialysate formulations and did not instruct medical staff to verify that fluid was flowing during use.

The recall record does not specify what actions affected consumers or healthcare providers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: US nationwide distribution Quantity: 1243400 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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