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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

NxStage Medical Inc: NxStage PureFlow-B Dialysate Recalled Due to Bursting Bags and Acid Risk

Agency Publication Date: June 20, 2024
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Summary

NxStage Medical Inc. has recalled approximately 1,316,936 units of PureFlow-B Solution, a premixed dialysate used for hemodialysis. The recall was initiated because the smaller chamber of the two-chamber bag may burst while being mixed by medical staff prior to use. This defect can lead to the release of a highly acidic electrolyte fluid that can cause chemical burns and creates a significant slip-and-fall hazard.

Risk

The fluid inside the small chamber has a pH level of less than 2.0, making it highly acidic and capable of causing chemical burns if it contacts skin or eyes. Additionally, the spilled liquid on clinical floors creates a slip hazard that could lead to fall injuries for patients or healthcare providers.

What You Should Do

  1. Check your inventory for NxStage PureFlow-B Solution with Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, or RFP-456.
  2. Verify the specific lot numbers on your packaging against the extensive list of affected lots, which include series such as RFP-400 (Lots Q2211552 through Q2402429), RFP-401 (Lots Q2211399 through Q2403762), and other listed RFP series numbers.
  3. Use extreme caution when attempting to mix the two chambers of the PureFlow-B Solution bag to avoid sudden bursting and potential exposure to the acidic fluid.
  4. If a bag bursts, avoid direct contact with the spilled fluid and ensure the area is immediately cleaned and dried to prevent slip and fall accidents.
  5. Contact your healthcare provider or NxStage Medical Inc. at 1-888-463-6332 for further instructions regarding affected product and potential replacement or refund options.
  6. Report any adverse events or quality problems to the FDA's MedWatch program at 1-888-463-6332 (1-888-INFO-FDA) or through www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NxStage PureFlow-B Solution (RFP-400)
Model / REF:
RFP-400
M535RFP4000
Lot Numbers (85):
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
Product: NxStage PureFlow-B Solution (RFP-401)
Model / REF:
RFP-401
M535RFP4010
Lot Numbers (338):
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
Product: NxStage PureFlow-B Solution (RFP-402)
Model / REF:
RFP-402
M535RFP4020
Lot Numbers:
Q2211349
Q2211236
Q2211327
Q2211548
Q2304102
Q2304103
Q2304104
Q2305589
Q2305591
Q2305590
Q2310111
Q2311566
Q2312575
Product: NxStage PureFlow-B Solution (RFP-403)
Model / REF:
RFP-403
M535RFP4030
Lot Numbers:
Q2211326
Q2310197
Q2311419
Q2311420
Product: NxStage PureFlow-B Solution (RFP-404)
Model / REF:
RFP-404
M535RFP4040
Lot Numbers (217):
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
Product: NxStage PureFlow-B Solution (RFP-406)
Model / REF:
RFP-406
M535RFP4060
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
Product: NxStage PureFlow-B Solution (RFP-453)
Model / REF:
RFP-453
M535RFP4530
Lot Numbers:
Q2211543
Q2310112
Q2311343
Q2311342
Q2311341
Q2312712
Q2401266
Product: NxStage PureFlow-B Solution (RFP-454)
Model / REF:
RFP-454
M535RFP4540
Lot Numbers:
Q2211542
Q2211408
Q2211407
Q2310110
Q2311498
Q2311520
Q2311521
Q2311499
Q2312719
Q2312717
Q2312716
Q2312720
Product: NxStage PureFlow-B Solution (RFP-456)
Model / REF:
RFP-456
M535RFP4560
Lot Numbers:
Q2308361
Q2308360
Q2309680
Q2309877
Q2309679
Q2309875
Q2309876
Q2310034
Q2310035
Q2310254
Q2312641
Q2311344
Q2311489
Q2311522

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94641
Status: Active
Manufacturer: NxStage Medical Inc
Sold By: NxStage Medical Inc
Manufactured In: United States
Units Affected: 1316936 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.