DELFLEX Peritoneal Dialysis Solution
Fresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
Stop using the recalled DELFLEX solution immediately and 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 with attached stay-safe Exchange Set due to potential leaks from perforations in bags, which could compromise sterility.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only
| Product | Lot code | Recall # |
|---|---|---|
| 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | 25CU02002, 25CU02011, 25CU02012, 25CU02013 | D-0513-2026 |
| 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. | 25CU02007, 25CU02008, 25CU02009 | D-0512-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Fresenius Medical Care Holdings, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification