CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

Check=Flo Performer Introducer, Reference recalled by Cook Incorporated

Cook Incorporated is recalling Check=Flo Performer Introducer, Reference, distributed nationwide in the US. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00827002089570, Lot Number 16376242

Quantity recalled89 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-1787-2025
FDA event ID: 96703
Recalling firm: Cook Incorporated, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 17 Apr 2025
FDA classified: 16 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Apr 2025	Recall initiated by company
16 May 2025	Classified by FDA	+29 days
28 May 2025	Published in enforcement report	+12 days

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

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Product as listed by the FDA

Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

Nationwide

Questions about this recall

Is Check=Flo Performer Introducer, Reference recalled?

Yes. Cook Incorporated recalled Check=Flo Performer Introducer, Reference on 17 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1787-2025.

Why was it recalled?

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Which lots are affected?

UDI/DI 00827002089570, Lot Number 16376242

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

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.

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