# FDA recall D-0513-2026

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2026-04-06.

## Product

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.

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0513-2026
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-06
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0513-2026

## Citation

> AI Analytics. FDA recall D-0513-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0513-2026. Source: US FDA. Licensed CC0.

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