Fresenius Kabi Usa, Llc: Delflex, Dextrose Peritoneal Dialysis Solution With Attached Stay-safe Exchange Set For Intraperitoneal Dialysis Only, 1.5% Dex. Lm/lc, 2l 5pk, Par...
Fresenius Kabi is recalling DELFLEX Dextrose Peritoneal Dialysis Solution (1.5% DEX, 2L 5PK, Part Number 054-20221) distributed nationwide because some bags may have small holes that could allow leaks and compromise sterility. This product is used for intraperitoneal dialysis. The recall affects patients who received this dialysis solution across all U.S. states.
- Recalling firm
- Fresenius Kabi USA, LLC
- 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.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/020a3744-de72-44db-9b4d-8da5f2886eba