FDAHealthApril 6, 2026
Fresenius Medical Care Holdings, Inc. — 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
⚠️ Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 6, 2026
Nationwide in the USA
What's affected?
- Product
- 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.
- Lot code
- 25CU02007
Additional details
Lot #: 25CU02007, 25CU02008, 25CU02009
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 37,215 bags.
Get Health recall alerts
Delivered to your inbox. Free. No account required.