FDA DrugClass IINotable

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

Date: 2026-05-13
Brand: Fresenius Medical Care Holdings, Inc.
Category: Drug
FDA Class: Class II

Description

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

Hazard

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

Remedy

37,215 bags

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