Cook Incorporated Recalls Check=Flo Performer Introducers for Incorrect Sheath Sizing
Cook Incorporated is recalling Check=Flo Performer Introducer devices due to potential incorrect introducer sheath sizing that may affect device functionality.
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: This is an FDA Class II medical device recall involving a manufacturing defect (incorrect sheath sizing) in a surgical/interventional device that could affect proper device function. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, which per the rubric scores at 3 (High).
Plain-English summary
Cook Incorporated is recalling Check=Flo Performer Introducer devices (10.0Fr) identified in affected lots due to a manufacturing defect. Devices from the affected lots may contain an incorrectly sized introducer sheath, which could affect proper device function during use.
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.
Patients and healthcare providers with affected devices should contact Cook Incorporated. Healthcare providers should determine whether any recalled devices have been used and evaluate the need for patient follow-up.
The recalled product
- Product
- Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
- Manufacturer
- Cook Incorporated
- Hazard
- manufacturing-defect
- incorrect-sizing
- device-malfunction
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 00827002086869
- Lot Number 16376248
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03