Reported Jun 26, 2024 · Ongoing

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

NxStage Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NxStage Medical Inc · 350 Merrimack St · Lawrence, MA · 01843-1748

Is this the product you have?

- 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

Lot codes and dates: Catalog NumberRFP-400
Primary Device IdentifierM535RFP4000
Catalog NumberRFP-401
Primary Device IdentifierM535RFP4010
Catalog NumberRFP-402
Primary Device IdentifierM535RFP4020
Catalog NumberRFP-403
Primary Device IdentifierM535RFP4030
Catalog NumberRFP-404
Primary Device IdentifierM535RFP4040
Catalog NumberRFP-405
Primary Device IdentifierM535RFP4050
Catalog NumberRFP-406
Primary Device IdentifierM535RFP4060
Catalog NumberRFP-453
Primary Device IdentifierM535RFP4530
Catalog NumberRFP-454
Primary Device IdentifierM535RFP4540
Catalog NumberRFP-456
Primary Device IdentifierM535RFP4560
RFP-400 Lot Numbers
85 of 85 codes
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
Q2306996
Q2306915
Q2306920
Q2306916
Q2306922
Q2306679
Q2306832
Q2308427
Q2308425
Q2308426
Q2309805
Q2309803
Q2309798
Q2309801
Q2309804
Q2309802
Q2309800
Q2309799
Q2310032
Q2310033
Q2310031
Q2310029
Q2310030
Q2311574
RFP-401 Lot Numbers
338 of 338 codes
Q2211399
Q2211325
Q2211402
Q2211473
Q2211470
Q2211324
Q2211316
Q2211318
Q2211395
Q2211403
Q2211484
Q2211474
Q2211317
Q2211401
Q2211323
Q2211394
Q2211398
Q2211319
Q2211472
Q2211396
Q2211406
Q2211397
Q2211479
Q2211481
Q2211404
Q2211322
Q2211546
Q2211321
Q2211405
Q2211480
Q2211471
Q2211477
Q2211476
Q2211485
Q2211320
Q2211478
Q2211475
Q2211400
Q2212628
Q2212629
Q2212630
Q2301023
Q2301373
Q2301104
Q2301105
Q2301025
Q2301244
Q2301245
Q2301024
Q2301248
Q2301376
Q2301374
Q2301026
Q2301246
Q2301175
Q2301103
Q2301182
Q2301247
Q2301179
Q2301375
RFP-402 Lot Numbers
Q2211349
Q2211236
Q2211327
Q2211548
Q2304102
Q2304103
Q2304104
Q2305589
Q2305591
Q2305590
Q2310111
Q2311566
Q2312575
RFP-403 Lot NumbersQ2211326 Q2310197 Q2311419 Q2311420
RFP-404 Lot Numbers
217 of 217 codes
Q2211389
Q2211549
Q2211391
Q2211393
Q2211310
Q2211232
Q2211233
Q2211390
Q2211229
Q2211311
Q2211230
Q2211228
Q2211392
Q2211231
Q2212626
Q2212627
Q2301372
Q2301109
Q2301110
Q2301100
Q2301250
Q2301112
Q2301241
Q2301187
Q2301098
Q2301254
Q2301243
Q2301251
Q2301188
Q2301252
Q2301111
Q2301099
Q2301102
Q2301368
Q2301371
Q2301367
Q2301369
Q2301366
Q2301370
Q2301242
Q2301101
Q2301253
Q2302603
Q2302608
Q2302533
Q2302702
Q2302528
Q2302610
Q2302604
Q2302701
Q2302613
Q2302606
Q2302403
Q2302531
Q2302611
Q2302605
Q2302612
Q2302404
Q2302530
Q2302529
RFP-406 Lot Numbers
Q2211483
Q2211482
Q2211544
Q2211545
Q2301186
Q2301185
Q2301183
Q2301184
Q2302472
Q2302534
Q2302535
Q2302473
Q2303034
Q2303959
Q2303960
Q2303035
Q2303036
Q2303037
Q2304299
Q2304197
Q2306753
Q2306754
Q2306752
Q2306755
Q2306756
Q2308428
Q2309736
Q2309734
Q2309735
Q2310195
Q2310196
Q2310257
Q2401078
Q2401079
RFP-453 Lot NumbersQ2211543 Q2310112 Q2311343 Q2311342 Q2311341 Q2312712 Q2401266
RFP-454 Lot Numbers
Q2211542
Q2211408
Q2211407
Q2310110
Q2311498
Q2311520
Q2311521
Q2311499
Q2312719
Q2312717
Q2312716
Q2312720
RFP-456 Lot Numbers
Q2308361
Q2308360
Q2309680
Q2309877
Q2309679
Q2309875
Q2309876
Q2310034
Q2310035
Q2310254
Q2312641
Q2311344
Q2311489
Q2311522
Amount recalled: 1316936 units

Where it was sold

Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403… Jun 4, 2025

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