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DRUG RECALLMODERATE
DELFLEX Peritoneal Dialysis Solution
Fresenius recalls DELFLEX PD solution 2L 5PK over potential sterility-compromising leaks.
What to do
Stop using the affected product immediately. Contact Fresenius Medical Care for instructions on returning the product and obtaining a replacement.
Why it was recalled
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution 1.5% LM/LC, 2L 5PK (Part Number 054-20221) due to potential leaks from bag perforations that may compromise sterility.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Recall # |
|---|---|
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | D-0513-2026 |
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | D-0512-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Fresenius Medical Care Holdings, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification