# FDA recall Z-2150-2024

> **Outset Medical, Inc.** · Class II · device recall initiated 2024-04-30.

## Product

TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.

## Reason for recall

A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

## Distribution

US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK, MA, WV, IN, KY, AZ, LA, NE, KS, NJ, CT, NM, CO, SC, TX, PA, NY, OH.

## Key facts

- **Recall number:** Z-2150-2024
- **Recalling firm:** Outset Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-30
- **Report date:** 2024-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2150-2024

## Citation

> AI Analytics. FDA recall Z-2150-2024. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2150-2024. Source: US FDA. Licensed CC0.

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