Lower riskMedical device recall · FDA · Published September 16, 2024
Cook Check-Flo Performer Introducer Set: White Caps May Disconnect
Cook recalls Check-Flo Performer Introducer Sets with reference part number RCF-5.0-35-45-J due to white caps potentially disconnecting, which could cause medical complications during use.
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
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Contact the company
📍Recalling firmCook Incorporated750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Check-Flo Performer Introducer Set: White Caps May Disconnect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54019-cook-check-flo-performer-introducer-set-white-caps-may-disconnect. Based on FDA recall #Z-0045-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2025%22&limit=1).
Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to a risk that white caps may disconnect from the shaft, according to the FDA. The Food and Drug Administration announced the voluntary Class II recall on September 16, 2024.
How to tell if you have it
Brand: Cook
Product: Check-Flo Performer Introducer Set
Reference Part Number: RCF-5.0-35-45-J
Order Number: G27242
Lot Number: 15506769
Distribution: Australia
The hazard
The recall addresses complaints that the white caps connecting the shaft to the hub of the Check-Flo Performer Introducer Set may disconnect. The FDA stated that Cook Medical is conducting a removal of the affected lot.
Context
GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Other recent recalls include Cook Beacon Tip Centimeter Sizing Catheters (April 2, 2026), Cook Strange Bile Duct Stone Set (March 5, 2026), and Cook Flexor Check-Flo Introducers and Sets (November 26, 2025). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026).
How to tell if you have this one
Check for the reference part number RCF-5.0-35-45-J or order number G27242 on the product. These devices were sold with lot number 15506769.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device
Inspect the white caps for signs of disconnection or looseness.
How this recall unfolded
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0045-2025 (September 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0045-2025 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.