NxStage recalls specific dialysate sacks due to potential endotoxin levels exceeding safety standards for hemodialysis use. Affected units include SAK-301 to SAK-407 with specific lot numbers and expiration dates.
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
NxStage is recalling certain dialysate sacks that may contain endotoxin levels above the safety standard for hemodialysis. This could pose a risk to patients using these sacks for kidney treatments.
The dialysate sacks may have endotoxin levels higher than the ANSI/AAMI standard of 0.5 EU/ml when used to prepare dialysis fluid. This could potentially cause adverse reactions in patients undergoing hemodialysis.
Patients using hemodialysis treatments with the recalled dialysate sacks are most at risk. The affected units are specific models and lot numbers listed in the recall notice.
Check the product label for the model number (SAK-301 to SAK-407) and lot number. The recall includes specific expiration dates for each model.
Look for the model number (SAK-301 to SAK-407) and lot number on the dialysate sack.
The dialysate sacks may contain endotoxin levels exceeding the ANSI/AAMI safety standard for hemodialysis fluid.
SAK-301, SAK-302, SAK-303, SAK-304, SAK-306, SAK-307, SAK-402, SAK-405, SAK-406, and SAK-407 with specific lot numbers and expiration dates.
The recall does not specify a stop-use action, but affected units should be checked and replaced with safe alternatives as per the manufacturer's guidance.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2018 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-0811-2018 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.
