FDA recall D-0513-2026

Fresenius Medical Care Holdings, Inc. · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-04-06
Report date
2026-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0513-2026