FDA recall, , Moderate risk
Fresenius Medical Care DELFLEX Peritoneal Dialysis Solution
Delflex Peritoneal Dialysis Solution lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care, Renal Therapies Group, LLC, of Lawrence, Massachusetts, initiated a voluntary recall of Delflex Peritoneal Dialysis Solution products because of a lack of assurance of sterility. The recall began on October 14, 2026, and was added to the FDA's Enforcement Report on November 2, 2026. The products were distributed nationwide in the USA.
The affected products include Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, 2.5% Dextrose, and 4.25% Dextrose, each with Low Magnesium/ Low Calcium and an Attached stay safe Exchange Set, in 2,000 mL or 2,500 mL single-dose bags. Customers were notified by letter.
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What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Product details
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,000 mL - Single Dose Bag, Sterile and Non-Pyrogenic, Rx only, CAT.NO. 054-20221. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843
- NDC
- 46163-206-92
- Lot code
- 25JGPD045
- 25JGPD046
- 25JGPD060
- 25KGPD057
Product details
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT.NO. 054-25324. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843
- NDC
- 46163-212-94
- Lot code
- 25NGPD001
Product details
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay"safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. NO. 054-25322. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843
- NDC
- 46163-209-94
- Lot code
- 25JGPD069
- 25SGPD046
- 25SGPD059
- 25SGPD063
- 26EGPD022
Product details
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,000 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. No. 054-20222. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843
- NDC
- 46163-209-92
- Lot code
- 25DGPD002
- 25DGPD003
- 25KGPD027
- 25KGPD042
- 25SGPD033
- 26AGPD033
- 26AGPD054
Product details
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. NO. 054-25321. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843
- NDC
- 46163-206-94
- Lot code
- 25HGPD037
- 26CGPD074
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
Nationwide in the USA.
- Recalled by
- NxStage Medical IncLawrence, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100130
- Recall numbers
- D-0167-2027 to D-0171-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from NxStage Medical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
NxStage Medical began the recall
FDA posted the recall to its Enforcement Report
FDA rated the recall Class II (moderate risk) · Added to Recall Canary
Summary updated
