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Delflex Peritoneal Dialysis Solution
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DRUG RECALLMODERATE

Delflex Peritoneal Dialysis Solution

Fresenius Medical Care is recalling Delflex Peritoneal Dialysis Solution due to potential bag leaks and a lack of sterility assurance.

What to do

Inspect the dialysis solution bags for any signs of leakage or damage before use. If a leak is detected, do not use the product and contact your healthcare provider or Fresenius Medical Care for further instructions.

Posted
Updated
Recall No.
D-0513-2026
Agency
Firm
Fresenius Medical Care Holdings, Inc.
Recall ID
98829
Status
ONGOING

Why it was recalled

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

How to identify it

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.

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification