# FDA recall Z-2083-2021

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

## Product

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.

## Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

## Distribution

US Distribution to: TX only

## Key facts

- **Recall number:** Z-2083-2021
- **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-2083-2021

## Citation

> AI Analytics. FDA recall Z-2083-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2083-2021. Source: US FDA. Licensed CC0.

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