Fresenius Medical Care Holdings, Inc. recalls DELFLEX
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Product
- 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.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 6, 2026
- Reported
- May 13, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 43,225 bags
- Lot / codes
- Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0513-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0513-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.