NxStage recalls PureFlow-B Solution dialysate bags with catalog numbers RFP-400 to RFP-456 due to small chamber bursting during mixing, risking skin/eye contact or slips from spilled fluid.
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.
NxStage is recalling certain PureFlow-B Solution dialysate bags because the small chamber can burst when nurses mix the two chambers. This may cause harmful contact with skin or eyes, or lead to slips and falls from spilled fluid.
The small chamber in the bag has a low pH (less than 2.0) that can burst when mixed with the larger chamber. This bursting may cause the fluid to spill, leading to skin or eye contact injuries or slips and falls.
Healthcare professionals using these dialysate bags for hemodialysis patients are most at risk. Patients receiving treatment with the recalled products could also be affected.
Check for catalog numbers RFP-400 through RFP-456 on the bag. The lot numbers listed in the recall record indicate specific batches to avoid.
Look for catalog numbers RFP-400 to RFP-456 on the bag and verify the lot numbers against the list provided in the recall.
The small chamber can burst when nurses mix the two chambers, risking skin/eye contact or slips from spilled fluid due to the low pH (less than 2.0) of the electrolyte fluid.
Check for catalog numbers RFP-400 through RFP-456 on the bag. The specific lot numbers listed in the recall record indicate which batches to avoid.
The recall record does not specify a remedy, so contact NxStage Medical Inc directly for guidance.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-2160-2024 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-2160-2024 from NxStage. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
