# FDA recall Z-0186-2022

> **Cook Inc.** · Class II · device recall initiated 2021-09-28.

## Product

Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069  The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

## Reason for recall

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

## Distribution

Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA. Foreign distribution to Germany, Finland, Italy, Netherlands, and Switzerland.

## Key facts

- **Recall number:** Z-0186-2022
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-28
- **Report date:** 2021-11-10
- **Termination date:** 2024-02-28

- **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-0186-2022

## Citation

> AI Analytics. FDA recall Z-0186-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0186-2022. Source: US FDA. Licensed CC0.

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