NxStage recalls PureFlow B Solution-RFP-400 dialysate bags with risk of small chamber bursting, causing injury if contact with eyes/skin occurs. Affected lot numbers listed.
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
NxStage is recalling PureFlow B Solution-RFP-400 dialysate bags because a small chamber can burst, potentially causing injury if electrolyte fluid contacts eyes or skin. This recall affects patients using hemodialysis treatments with the specific lot numbers listed.
The small chamber in the dialysate bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin. This risk occurs during normal use when the bag is handling the dialysis solution.
Patients using hemodialysis treatments with the recalled PureFlow B Solution-RFP-400 bags are most at risk. Healthcare providers administering the dialysis treatment may also be affected.
Check the lot number on the bag. Affected lots include F1709268, F1709269, F1709276, F1709277, F1710321, and other specific numbers listed in the recall notice.
Look for the lot number on the dialysate bag to determine if it's affected.
The small chamber in the dialysate bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Affected lot numbers include F1709268, F1709269, F1709276, F1709277, F1710321, and other specific numbers listed in the recall notice.
The recall does not require immediate stop use; however, you should check the lot number to see if your product is affected.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-0500-2019 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-0500-2019 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.
