FDA Device recall Z-2160-2024

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4…

FDA Device
Class II
ongoing
Published 2024-06-26

On 2024-06-26 the FDA classified a Class II recall of NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4… by Nxstage Medical, citing the smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage P….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2160-2024
Classification	Class II
Status	ongoing
Initiated	2024-05-14
Published	2024-06-26
Last updated	2026-09-13 11:57 UTC
Company	Nxstage Medical
Distribution	US

Product

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456

Reason

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

Identifiers

code_info	Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M5… Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M535RFP4010; Catalog Number: RFP-402, Primary Device Identifier: M535RFP4020; Catalog Number: RFP-403, Primary Device Identifier: M535RFP4030; Catalog Number: RFP-404, Primary Device Identifier: M535RFP4040; Catalog Number: RFP-405, Primary Device Identifier: M535RFP4050; Catalog Number: RFP-406, Primary Device Identifier: M535RFP4060; Catalog Number: RFP-453, Primary Device Identifier: M535RFP4530; Catalog Number: RFP-454, Primary Device Identifier: M535RFP4540; Catalog Number: RFP-456, Primary Device Identifier: M535RFP4560; RFP-400 Lot Numbers: Q2211552 Q2211554 Q2211553 Q2211312 Q2211551 Q2211555 Q2211313 Q2211314 Q2211556 Q2211315 Q2301381 Q2302705 Q2302703 Q2302706 Q2302704 Q2303710 Q2303737 Q2303709 Q2303790 Q2303708 Q2303707 Q2304269 Q2304267 Q2304268 Q2305365 Q2305429 Q2305366 Q2305416 Q2305594 Q2305428 Q2306919 Q2306918 Q2306834 Q2306921 Q2306833 Q2306917 Q230

code_info

Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M5…

Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M535RFP4010; Catalog Number: RFP-402, Primary Device Identifier: M535RFP4020; Catalog Number: RFP-403, Primary Device Identifier: M535RFP4030; Catalog Number: RFP-404, Primary Device Identifier: M535RFP4040; Catalog Number: RFP-405, Primary Device Identifier: M535RFP4050; Catalog Number: RFP-406, Primary Device Identifier: M535RFP4060; Catalog Number: RFP-453, Primary Device Identifier: M535RFP4530; Catalog Number: RFP-454, Primary Device Identifier: M535RFP4540; Catalog Number: RFP-456, Primary Device Identifier: M535RFP4560; RFP-400 Lot Numbers: Q2211552 Q2211554 Q2211553 Q2211312 Q2211551 Q2211555 Q2211313 Q2211314 Q2211556 Q2211315 Q2301381 Q2302705 Q2302703 Q2302706 Q2302704 Q2303710 Q2303737 Q2303709 Q2303790 Q2303708 Q2303707 Q2304269 Q2304267 Q2304268 Q2305365 Q2305429 Q2305366 Q2305416 Q2305594 Q2305428 Q2306919 Q2306918 Q2306834 Q2306921 Q2306833 Q2306917 Q230

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.