FDAFDA · Food and drugs·Recall number D-0512-2026
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.
Published May 13, 2026 · Recall initiated: April 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 25CU02007, 25CU02008, 25CU02009
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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