# FDA recall D-0608-2024

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2024-06-18.

## Product

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94

## Reason for recall

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0608-2024
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-06-18
- **Report date:** 2024-07-24

- **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-0608-2024

## Citation

> AI Analytics. FDA recall D-0608-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0608-2024. Source: US FDA. Licensed CC0.

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