“Cook Flexor Check-Flo Introducer Ansel Modification: Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61541-cook-flexor-check-flo-introducer-ansel-modification-mislabeling-risk. Based on FDA recall #Z-0388-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0388-2022%22&limit=1).
Cook Inc. recalled Flexor Check-Flo Introducer Ansel Modification units on Nov. 12, 2021, because mislabeled packages may contain the wrong device size, according to the FDA. The agency announced the Class II recall under number Z-0388-2022.
Products packaged with a label stating 6FR may contain a 7FR device and vice versa. The FDA stated the hazard is the mislabeling of the Flexor Check-Flo Introducer Ansel Modification.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducers and Sets (Nov. 26, 2025), Cook Ring Transjugular Intrahepatic Access Sets (Nov. 26, 2025), and Cook Rupsch-Uchida Liver Access Sets (Nov. 26, 2025).
How to tell if you have this one
Check for the model number KCFW-7.0-18/38-45-RB-ANL0-HC and order number G44155 on the device packaging. Products labeled with 6FR may contain a 7FR device and vice versa.
Brand
Cook
Product
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA
Recall number
Product, codes & lots
Quantity
Z-0387-2022
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.; Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370
50 units
Z-0388-2022
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.; Lot Number: 13911710 UDI: (01)00827002441552(17)240422(10)13911710
47 units
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for the model number KCFW-7.0-18/38-45-RB-ANL0-HC and order number G44155 on the device packaging.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Florida, Georgia, Kansas, Michigan, Minnesota, Missouri, New York, North Carolina, Oklahoma, Texas.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0388-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0388-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.