CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report

Flexor Check-Flo Introducer Ansel Modification recalled by Cook

Cook is recalling Flexor Check-Flo Introducer Ansel Modification, distributed in 14 states. The recall was initiated on 12 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0387-2022
FDA event ID: 89072
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2021
FDA classified: 16 Dec 2021
Reported: 22 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

12 Nov 2021	Recall initiated by company
16 Dec 2021	Classified by FDA	+34 days
22 Dec 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Where it was distributed

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

Alabama Arizona California Delaware Florida Georgia Kansas Michigan Minnesota Missouri North Carolina New York Oklahoma Texas

Questions about this recall

Is Flexor Check-Flo Introducer Ansel Modification recalled?

Yes. Cook recalled Flexor Check-Flo Introducer Ansel Modification on 12 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0387-2022.

Why was it recalled?

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

Which lots are affected?

Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cook

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Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS II	Skinny Needle with Chiba Tip recalled by Cook	Cook	Other	Nationwide
22 Dec 2021Device	CLASS II	Flexor Check-Flo Introducer Ansel Modification recalled by Cook	Cook	Labeling Errors	14 states
24 Nov 2021Device	CLASS II	Transseptal Needle, Trocar recalled by Cook	Cook	Device Malfunction	Nationwide
24 Nov 2021Device	CLASS II	Transseptal Needle with Catheter recalled by Cook	Cook	Foreign Material	Nationwide
10 Nov 2021Device	CLASS II	Flexor Check-Flo Introducer, Introducer Set recalled by Cook	Cook	Device Malfunction	15 states

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