# FDA recall Z-0420-2022

> **Abbott** · Class II · device recall initiated 2021-11-16.

## Product

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

## Reason for recall

As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was  manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in  length instead of the intended 5 cm in length.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.

## Key facts

- **Recall number:** Z-0420-2022
- **Recalling firm:** Abbott
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-16
- **Report date:** 2022-01-05
- **Termination date:** 2024-06-18

- **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-0420-2022

## Citation

> AI Analytics. FDA recall Z-0420-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0420-2022. Source: US FDA. Licensed CC0.

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