Rockwell Medical recalls DriSate DR-145 product code with sodium bicarbonate contamination in dextrose bags. This may affect hemodialysis treatments. Learn if you have the product and what to do.
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Rockwell Medical is recalling DriSate DR-14:5 product code due to small amounts of sodium bicarbonate in dextrose bags. This contamination could potentially affect hemodialysis treatments if used without proper testing.
The dextrose bags in the DriSate DR-145 product contain small amounts of sodium bicarbonate from a prior batch. This contamination could cause an imbalance in the dialysis solution if not properly tested or adjusted for by healthcare providers.
Hemodialysis patients and healthcare providers using DriSate DR-145 product code for acute or chronic hemodialysis treatments. Those most at risk are patients receiving treatment with this specific product.
Check for the product code DR-145 on the DriSate product label. The product was sold with lot number 28562-0220171. This product is used in hemodialysis treatments.
Look for the product code DR-145 and lot number 28562-0220171 on the DriSate product label.
The recall states that small amounts of sodium bicarbonate may be present, but the product is still intended for use in hemodialysis treatments with proper testing.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
The contamination could potentially affect the dialysis solution if not properly tested or adjusted by healthcare providers.
We’ve drafted a message you can send Rockwell Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1869-2018 — Rockwell Medical Rockwell Medical Hello, I own a Rockwell Medical that is covered by recall Z-1869-2018 from Rockwell Medical. 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.
