Official recall notice

FDA DrugClass IINotable

DELFLEX Recall (May 2026) – Fresenius Medical Care Holdings

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.

Recall date
2026-05-13
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

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