Reported Oct 16, 2024 · Ongoing

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers…

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Lot codes and dates
  • UDI-DI00827002272422
  • Lot Number15506769
Amount recalled
50 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

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