Fresenius Medical Care recalls DELFLEX peritoneal dialysis solution bags over possible leaks and sterility concerns
Some bags of DELFLEX dextrose dialysis solution (1.5% and 2.5%) may have small holes that cause leaks, so there is no assurance the solution is sterile, which is a risk for patients using it.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall 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.; DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part…
- Hazard
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Units
- 43,225 bags; 37,215 bags
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 4, 2026
- Recall started
- April 6, 2026
- FDA enforcement report
- May 13, 2026
- Identifiers
- Codes: Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
- FDA recall number: D-0513-2026
- Codes: Lot #: 25CU02007, 25CU02008, 25CU02009
- FDA recall number: D-0512-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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. | 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.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 43,225 bags; 37,215 bags
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