DELFLEX recall (Fresenius Medical Care Holdings, Inc.)
DrugClass IIOngoing
Summary: Fresenius Medical Care Holdings, Inc. is recalling 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.. Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What is being recalled
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.
Why
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #: 25CU02007, 25CU02008, 25CU02009
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0512-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 6, 2026 |
| Reported | May 13, 2026 |
| Company | Fresenius Medical Care Holdings, Inc. |
| Company location | Waltham, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 37,215 bags |
More recalls from Fresenius Medical Care Holdings, Inc. · all drug recalls · recalls from April 2026