# FDA recall Z-0789-2020

> **Abbott Medical** · Class II · device recall initiated 2019-12-09.

## Product

Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

## Reason for recall

Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic

## Key facts

- **Recall number:** Z-0789-2020
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-09
- **Report date:** 2020-01-15
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0789-2020

## Citation

> AI Analytics. FDA recall Z-0789-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0789-2020. Source: US FDA. Licensed CC0.

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