Check-Flo Performer Introducer Medical Device Recall Notice
Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a medical device with a structural/sizing defect that could impair function. The source does not report any illnesses or injuries, but the nature of the defect—an incorrectly sized introducer sheath—constitutes a risk-of-harm product where injury has not yet been reported, placing it at score 3.
Plain-English summary
Cook Incorporated is recalling certain Check-Flo Performer Introducer devices (14.0Fr, Reference Part Number RCFW-14.0-0-38-30-RB, Order Number G08957) due to a manufacturing defect. Devices from affected lots may contain an incorrectly sized introducer sheath.
The affected devices have been distributed worldwide, including across the United States and to Belgium, Germany, Spain, France, Ireland, Italy, Netherlands, Switzerland, South Africa, and Slovenia. Approximately 89 units are involved, with Lot Number 16376242 identified (UDI/DI 00827002089570).
Patients or healthcare providers who have one of these devices should contact Cook Incorporated for further information on how to proceed.
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
- Hazard
- Affected units
- 89
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.
Part of a larger recall action
This product is one of 2 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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