Fresenius Medical Care Holdings, Inc.: Delflex, Dextrose Peritoneal Dialysis Solution With Attached Stay-safe Exchange Set For Intraperitoneal Dialysis Only, 1.5% Dex. Lm/lc, 2l 5pk, Par...
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution (1.5% DEX, 2L 5-packs, Part Number 054-20221) distributed nationwide because bags may have small holes that could allow leaks and compromise sterility. This product is used for peritoneal dialysis, a kidney treatment administered at home or in clinical settings. The recall affects patients across all U.S. states and Washington, D.C.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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/9bc6eaca-c7f1-41f6-b11d-bafa58bfd27a