The Recall Desk
HighFDA (Devices)·Z-1787-2025·Announced 2025-05-28

Cook Recalls Check=Flo Performer Introducer for Incorrect Sheath Sizing

Cook Incorporated is recalling Check=Flo Performer Introducer (14.0Fr) because affected devices may contain an incorrectly sized introducer sheath.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The incorrectly sized introducer sheath represents a potential device malfunction risk, but the hazard is theoretical as stated in the source.

Plain-English summary

Cook Incorporated is recalling Check=Flo Performer Introducer, 14.0Fr (Reference Part Number RCFW-14.0-0-38-30-RB). The recall affects 89 units with Lot Number 16376242.

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

The recalled devices were distributed worldwide, including throughout the United States and to Belgium, Germany, Spain, France, Ireland, Italy, the Netherlands, Switzerland, South Africa, and Slovenia.

For additional information about this recall, contact Cook Incorporated or reference FDA recall number Z-1787-2025.

The recalled product

Product
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Manufacturer
Cook Incorporated
Category
Medical Device — Cardiovascular Introducer
Hazard
  • device-defect
  • sizing-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00827002089570
  • Lot Number 16376242

Distribution

Distributed nationwide across the United States.

Related recalls

Same category