Official recall notice

FDA DrugClass IINotable

FDA Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperiton

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.

Recommended action

What to do

37,215 bags

Product description

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

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