---
title: "Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-4... — FDA record Z-0388-2022 | Is It on Recall"
description: "Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa"
url: https://isitonrecall.com/recall/fda-device-z-0388-2022-flexor-check-flo-introducer-ansel-modification-model-number-kcfw-7-0-18-38-45-rb-anl0-hc-order-numbe/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 In... — FDA record Z-0388-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 12, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
- **Classification**: Class II
- **Recalling firm**: Cook Inc.
- **Quantity**: 47 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0388-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0388-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Number: 13911710 UDI: (01)00827002441552(17)240422(10)13911710 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Dec 22, 2021
- **Recall initiation date**: Nov 12, 2021
- **Center classification date**: Dec 16, 2021
- **Termination date**: Apr 26, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0388-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cook Inc. records](https://isitonrecall.com/brand/cook-inc/)