DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from perforations that may compromise sterility. The recall affects 37,215 bags distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a critical-use medical product (peritoneal dialysis solution) where sterility is essential and compromise poses risk of serious harm (infection, treatment failure). No illnesses or injuries are explicitly reported in the source text, but the hazard is not merely theoretical—perforations directly undermine the product's essential safety function.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set (1.5% DEX, 2L, 5-pack, Part Number 054-20221) due to a lack of assurance of sterility caused by potential leaks from perforations in the bags.
The affected product is Lot #25CU02007, 25CU02008, and 25CU02009. A total of 37,215 bags have been distributed nationwide in the USA.
Peritoneal dialysis patients using bags with perforations may be at risk if the bags leak, potentially compromising the sterile solution needed for safe intraperitoneal dialysis treatment. Patients should immediately stop using any bags from the recalled lots.
Patients who have received bags from the affected lots should contact Fresenius Medical Care or consult their healthcare provider. Do not use any products from Lot #25CU02007, 25CU02008, or 25CU02009.
The recalled product
- 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.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- sterility-assurance-failure
- potential-leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 25CU02007
- 25CU02008
- 25CU02009
Distribution
Distributed nationwide across the United States.