# FDA recall D-0604-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · drug recall initiated 2017-12-20.

## Product

DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.

## Reason for recall

Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

## Distribution

Product was distributed throughout the United States to patients and clinics.

## Key facts

- **Recall number:** D-0604-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-03-28
- **Termination date:** 2019-02-14

- **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-0604-2018

## Citation

> AI Analytics. FDA recall D-0604-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0604-2018. Source: US FDA. Licensed CC0.

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