Check-Flo Performer Introducer medical device recall for incorrect sheath sizing
Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA has classified this as a Class II recall. The hazard—an incorrectly sized sheath—is a product defect without any reported injuries or illnesses in the source text. This meets the criteria for a Moderate severity rating.
Plain-English summary
Cook Incorporated is recalling Check-Flo Performer Introducer devices, 10.0Fr, with Reference Part Number REF RCFW-10.0-0-38-30-RB and Order Number REF G08686. The recall affects 99 units with Lot Number 16376248 (UDI/DI 00827002086869).
The devices may contain an incorrectly sized introducer sheath, which could affect proper device function and clinical performance.
The affected devices have been distributed worldwide, including throughout the United States and to Belgium, Germany, Spain, France, Ireland, Italy, Netherlands, Switzerland, South Africa, and Slovenia. Healthcare providers and patients who have received these devices should contact Cook Incorporated for instructions on how to proceed.
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
- Affected units
- 99
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.
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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