Recalling firm
Fresenius Medical Care Holdings, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide in the USA
Firm state
MA
Product quantity
37,215 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product description
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.
Code / lot info
Lot #: 25CU02007, 25CU02008, 25CU02009
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.