# FDA recall Z-0851-2019

> **Cook Inc.** · Class II · device recall initiated 2018-12-21.

## Product

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

## Reason for recall

The products were manufactured with longer than specified sheaths.

## Distribution

The products were distributed to the following US states:  CA, CT, GA, MA, NY, PA, VA, and WI.

## Key facts

- **Recall number:** Z-0851-2019
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-21
- **Report date:** 2019-02-27
- **Termination date:** 2020-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0851-2019

## Citation

> AI Analytics. FDA recall Z-0851-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0851-2019. Source: US FDA. Licensed CC0.

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