HIGH

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...

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

Quick Facts at a Glance

Recall Date
April 6, 2026
Hazard Level
HIGH
Brand
Fresenius Medical Care Holdings
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

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: Lack of Assurance of Sterility: Potential leaks from perforations in bags.. Classification: Class II. Quantity: 37,215 bags. Distribution: Nationwide in the USA

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot #: 25CU02007
25CU02008
25CU02009
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE