# FDA recall Z-0388-2022

> **Cook Inc.** · Class II · device recall initiated 2021-11-12.

## Product

Flexor Check-Flo Introducer Ansel Modification  Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155  Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

## Reason for recall

Flexor Check-Flo Introducer Ansel Modification  mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

## Distribution

AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA

## Key facts

- **Recall number:** Z-0388-2022
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-12
- **Report date:** 2021-12-22
- **Termination date:** 2024-04-26

- **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-0388-2022

## Citation

> AI Analytics. FDA recall Z-0388-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0388-2022. Source: US FDA. Licensed CC0.

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