NxStage PureFlow-B Solution — Class II medical device recall Z-2160-2024
Ongoing recall by NxStage Medical Inc, reported 2024-06-26, distributed nationwide. The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prio
| Recall number | Z-2160-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NxStage Medical Inc, Lawrence, MA, United States |
| Recall initiated | 2024-05-14 |
| Classified | 2024-06-20 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,316,936 units |
| Lot numbers | Q2211228, Q2211229, Q2211230, Q2211231, Q2211232, Q2211233, Q2211236, Q2211310, Q2211311, Q2211312, Q2211313, Q2211314, Q2211315, Q2211316, Q2211317, Q2211318, Q2211319, Q2211320, Q2211321, Q2211322, Q2211323, Q2211324, Q2211325, Q2211326, Q2211327, Q2211349, Q2211389, Q2211390, Q2211391, Q2211392, Q2211393, Q2211394, Q2211395, Q2211396, Q2211397, Q2211398, Q2211399, Q2211400, Q2211401, Q2211402 and 460 more |
| Model numbers | RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2160-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.