DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for In… recall
FDA recall D-0513-2026 · initiated Apr 6, 2026
Fresenius Medical Care Holdings, Inc. recalled DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… in Apr 2026 — an FDA Class II recall (D-0513-2026) because Lack of Assurance of Sterility: Potential leaks from perforations in bags.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 43,225 bags
Details
- 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.
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 6, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… recalled?
- Fresenius Medical Care Holdings, Inc. recalled DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… in Apr 2026 — an FDA Class II recall (D-0513-2026) because Lack of Assurance of Sterility: Potential leaks from perforations in bags. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… recalled?
- Per the FDA enforcement record, the reason for recall D-0513-2026 was: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Is a recalled DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0513-2026.