# FDA recall Z-0783-2020

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

## Product

Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

## Reason for recall

Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

## Distribution

Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay

## Key facts

- **Recall number:** Z-0783-2020
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-09
- **Report date:** 2020-01-15
- **Termination date:** 2020-12-14

- **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-0783-2020

## Citation

> AI Analytics. FDA recall Z-0783-2020. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0783-2020. Source: US FDA. Licensed CC0.

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