CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report
Check=Flo Performer Introducer, 10., Reference recalled
Cook is recalling Check=Flo Performer Introducer, 10., 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
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-1786-2025
- FDA event ID
- 96703
- Recalling firm
- Cook, 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, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Questions about this recall
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 00827002086869, Lot Number 16376248
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96703| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Check=Flo Performer Introducer, 14., Reference recalled | Cook | Other | Nationwide |
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