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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

NxStage Medical, Inc.: 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

Agency Publication Date: November 27, 2018
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Affected Products

Product: 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.

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

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers
Product: 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.

Lot Numbers: Q1802398, Q1802428

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers
Product: 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.

Lot Numbers: Q1801222, Q1801341, Q1802396, Q1802397

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81445
Status: Resolved
Manufacturer: NxStage Medical, Inc.
Manufactured In: United States
Units Affected: 8 products (59100; 186476; 21071; 2189; 114777; 16585; 7275; 15880)

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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 · 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.