# FDA recall Z-2089-2021

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

## Product

The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

## Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

## Distribution

US Distribution to: TX only

## Key facts

- **Recall number:** Z-2089-2021
- **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-2089-2021

## Citation

> AI Analytics. FDA recall Z-2089-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2089-2021. Source: US FDA. Licensed CC0.

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