# FDA recall Z-2088-2021

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2021-04-28.

## Product

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

## Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

## Distribution

US Distribution to: TX only

## Key facts

- **Recall number:** Z-2088-2021
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-28
- **Report date:** 2021-07-28
- **Termination date:** 2022-08-08

- **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=Z-2088-2021

## Citation

> AI Analytics. FDA recall Z-2088-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2088-2021. Source: US FDA. Licensed CC0.

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