Lower riskMedical device recall · FDA · Published September 28, 2021
Cook Flexor Check-Flo Introducer Recall: Incorrect Radiopaque Marker Band Risk
Cook recalls Flexor Check-Flo Introducer with incorrect radiopaque marker band placement, potentially causing longer procedures during medical imaging. Affected lots may need replacement.
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.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Flexor Check-Flo Introducer Recall: Incorrect Radiopaque Marker Band Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61744-cook-flexor-check-flo-introducer-recall-incorrect-radiopaque-marker-band. Based on FDA recall #Z-0186-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2022%22&limit=1).
Cook Inc. recalled Flexor Check-Flo Introducer - Raabe Modification sets on Sept. 28, 2021, because the radiopaque marker band may be incorrectly positioned, potentially increasing procedural time, according to the FDA.
How to tell if you have it
Brand: Cook
Product: Flexor Check-Flo Introducer - Raabe Modification, Introducer Set
RPN: KCFW-5.0-38-90-RB-RAABE
GPN: G13069
Lot code: 13846597
The hazard
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip, according to the FDA. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
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 Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026).
How to tell if you have this one
Check for the product model RPN KCFW-5.0-38-90-RB-RAABE with lot number 13846597. The device is sold by Cook Inc. for medical use.
Brand
Cook
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
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.
Recall number
Product, codes & lots
Quantity
Z-0185-2022
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.; lot 13861362
48 (OUS)
Z-0186-2022
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.; lot 13846597
48 (US)
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Identify the lot number on the device packaging or label to determine if it is affected.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Massachusetts, Minnesota, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 2.4 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-0186-2022 (September 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0186-2022 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.