Data Composite

Recall D-0512-2026

US Class II Ongoing · initiated 2026-04-06

Recalling firm

Fresenius Medical Care Holdings, Inc., MA

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 for recall

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

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