D-0512-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2026
- Initiation Date
- April 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,215 bags
Product Description
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 for Recall
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 25CU02007, 25CU02008, 25CU02009