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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81445

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
NxStage Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0500-2019
Recall number
Z-0500-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
59100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1709268, F1709269, F1709276, F1709277, F1710321, F1711329, F1711334, F1711339, F1711340, F1711341, F1711342, Q1711804, Q1711805, Q1711806, Q1711807, Q1711846, Q1711847, Q1711848, Q1711849, Q1711850, Q1711851, Q1711856, Q1711857, Q1711862, Q1712958, Q1712964, Q1803629, Q1803630, Q1803688, Q1803689, Q1803757, Q1803830, Q1803831, Q1803832

Distribution pattern

US Nationwide Distribution.

device · product 2 of 8

NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0501-2019
Recall number
Z-0501-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
186476

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1708229, F1709262, F1709263, F1709264, F1709265, F1709266, F1709273, F1709274, F1709275, F1709278, F1709279, F1709280, F1709281, F1709282, F1709283, F1709284, F1709286, F1709287, Q1709423, Q1709428, Q1709429, F1710296, F1710297, F1710298, F1710315, F1710316, F1710317, F1710318, F1710319, F1710320, F1710324, F1710325, F1710326, Q1710613, Q1710614, Q1710615, F1711330, F1711337, F1711338, Q1711674, Q1711675, Q1711677, Q1711683, Q1711721, Q1711727, Q1711728, Q1711729, Q1711795, Q1711796, Q1711797, Q1711798, Q1711799, Q1711800, Q1711801, Q1711802, Q1711803, Q1712024, Q1712026, Q1712027, Q1712032, Q1712089, Q1712090, Q1712138, Q1712139, Q1712140, Q1712141, Q1712142, Q1801145, Q1801346, Q1801347, Q1802391, Q1802392, Q1802429, Q1802430, Q1802431, Q1802432, Q1802433, Q1802434, Q1802435, Q1802436, Q1802503, Q1802504, Q1802505, Q1802506, Q1802513, Q1803631, Q1803632, Q1803633, Q1803634, Q1803635, Q1803681, Q1803751, Q1803752, Q1803753, Q1803756, Q1803758, Q1803759, Q1803760, Q1803773, Q1803828, Q1803829, Q1803833, Q1803846, Q1804092, Q1804093, Q1804094, Q1804905

Distribution pattern

US Nationwide Distribution.

device · product 3 of 8

NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0502-2019
Recall number
Z-0502-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
21071

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1708255, F1709285, F1710323, Q1711861, Q1711863, Q1712021, Q1712022, Q1712023, Q1712033, Q1801345, Q1802399, Q1802400

Distribution pattern

US Nationwide Distribution.

device · product 4 of 8

NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0503-2019
Recall number
Z-0503-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
2189

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: Q1802398, Q1802428

Distribution pattern

US Nationwide Distribution.

device · product 5 of 8

NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0504-2019
Recall number
Z-0504-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
114777

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1708230, F1708231, F1708234, F1708235, F1708237, F1708245, F1708246, F1708247, F1708250, F1708251, F1708253, F1708254, F1708256, F1709260, F1709261, F1709267, F1710327, F1710328, F1711343, F1711344, F1711345, Q1711844, Q1711853, Q1711854, Q1711855, Q1712025, Q1712091, Q1712092, Q1712137, Q1801146, Q1801147, Q1801148, Q1801149, Q1801151, Q1801202, Q1801221, Q1801225, Q1801226, Q1801335, Q1801336, Q1801337, Q1801338, Q1801339, Q1801340, Q1802507, Q1802508, Q1802509, Q1802510, Q1802511, Q1802512, Q1803685, Q1803686, Q1803687, Q1803690, Q1803750, Q1803754, Q1803755, Q1803774, Q1803775, Q1803776, Q1803847, Q1803848, Q1803849, Q1804888

Distribution pattern

US Nationwide Distribution.

device · product 6 of 8

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0505-2019
Recall number
Z-0505-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
16585

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1710314, Q1712034, Q1801223, Q1801224, Q1801344, Q1802451, Q1803684, Q1803817, Q1804904

Distribution pattern

US Nationwide Distribution.

device · product 7 of 8

NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0506-2019
Recall number
Z-0506-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
7275

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: Q1801222, Q1801341, Q1802396, Q1802397

Distribution pattern

US Nationwide Distribution.

device · product 8 of 8

NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Z-0507-2019
Recall number
Z-0507-2019
Initiated
October 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
NxStage Medical, Inc.
Quantity
15880

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Code information

Lot Numbers: F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, Q1803816

Distribution pattern

US Nationwide Distribution.