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 - Lack of Assurance of Sterility: Po

Source: FDA | Recall date: 05/13/2026

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Affected 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

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

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

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