FDA Drugs recall ·
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… recall
- Recall number
- D-0512-2026
- Date
- (initiated April 6, 2026)
- Company / brand
- Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920, Waltham, MA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 37,215 bags
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 25CU02007, 25CU02008, 25CU02009
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0512-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.