In the agency's Nov 11, 2026 enforcement report · Ongoing
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 350 Merrimack St · Lawrence, MA · 01843-1748
Is this the product you have?
- 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 codes and dates
Lot #: 25JGPD045Lot 25JGPD046Lot 25JGPD060Exp 1/31/202725KGPD057Exp 2/28/2027
- Amount recalled
- 4,232 cases (5 bags per case)
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility:complaints have been received related to potential leaks from small perforations in the print area on the primary bag in the affected lots.
This product could cause temporary or reversible health problems — stop using it.
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