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…
NxStage Medical Inc.
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.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: NxStage Medical Inc · 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
The agency has not ranked the risk yet — treat the notice as a caution.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new NxStage Medical Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.