Fresenius Medical Care Delflex Peritoneal Dialysis Solution
Delflex, Dextrose Peritoneal Dialysis Solution may have leaks from perforations in bags, lacking assurance of sterility.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Fresenius Medical Care Holdings, Inc., of Waltham, Massachusetts, began a recall of Delflex Dextrose Peritoneal Dialysis Solution on April 6, 2026, because potential leaks from perforations in bags could lack assurance of sterility. The FDA added the recall to its Enforcement Report and classified it on May 4, 2026, with nationwide distribution in the USA.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your set affected?
2 products
Affected if its lot code is listed.
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
- Lot
- 25CU02002
- 25CU02011
- 25CU02012
- 25CU02013
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
- Lot
- 25CU02007
- 25CU02008
- 25CU02009
Details
- Company began the recall
- Sold in
Nationwide in the USA
- Event ID
- 98829
- Recall numbers
- D-0512-2026 to D-0513-2026
- Company
- Fresenius Medical Care Holdings, Inc.Waltham, Massachusetts
- Hazard
- Sterility failure
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
