Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2
Recalled May 13, 2026 · FDA recall D-0513-2026 · Fresenius Medical Care Holdings
Hazard
Lack of Assurance of Sterility: Potential leaks from perforations in bags. · FDA Class II
Units
43,225 bags
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →