Recall: D-0512-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-06Initiated

OngoingStatus

Fresenius Medical Care HoldingFirm

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.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.