Cook recalls Check-Flo Performer Introducer with longer sheaths that may cause injury during use. Affected units include specific catalog and lot numbers. Consumers should contact Cook for details.
“Cook Check-Flo Performer Introducer Recall: Longer Sheaths Risk Injury.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69238-cook-check-flo-performer-introducer-recall-longer-sheaths-risk-injury. Based on FDA recall #Z-0851-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0851-2019%22&limit=1).
The Food and Drug Administration announced on Dec. 21, 2018, that Cook Inc. voluntarily recalled Check-Flo Performer Introducers due to manufacturing defects. The agency classified the recall as Class II.
How to tell if you have it
Brand: Cook
Product: Check-Flo Performer Introducer
Catalog Number: RCFW-5.0-25-45-RB-CHB
GPN: G11571
Lot code: 8858425
Quantity: 24 units
The hazard
The products were manufactured with sheaths that are longer than specified, according to the FDA.
Context
GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent similar product recalls include Cook Flexor Check-Flo Introducers and Sets (Nov. 26, 2025), Cook Rupsch-Uchida Liver Access Sets (Nov. 26, 2025), and Cook Ring Transjugular Intrahepatic Access Sets (Nov. 26, 2025).
How to tell if you have this one
Check for the catalog number RCFW-5.0-25-45-RB-CHB and lot number 8858425 on the device. The product was sold by Cook Inc. and is used in medical procedures.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Cook
Reach out to Cook Inc. directly to confirm if your device is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Georgia, Massachusetts, New York, Pennsylvania, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 16 months 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-0851-2019 (December 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0851-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.