Cook Inc. Recalls Flexor Check-Flo Introducers Due to Incorrect Packaging
Cook Inc. is recalling 25 Flexor Check-Flo Introducers because some packages labeled as 6.0Fr actually contained 5.0Fr devices.
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 recall is classified as FDA Class II, and the hazard involves incorrect packaging/labeling of device sizes without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cook Inc. is recalling 25 units of the Flexor Check-Flo Introducer, a catheter introducer intended for the introduction of balloons, closed and non-tapered end catheters, or diagnostic and interventional devices. The specific catalog number for the affected product is KCFW-6.0-35-70-RB-HFANL0-HC, and the lot number is 6166304.
The recall was initiated due to incorrect packaging. Reports indicate that some packages labeled as 6.0Fr actually contained 5.0Fr devices. This discrepancy could lead to the use of the wrong device size during medical procedures.
The affected products were distributed in the states of California, Florida, Oklahoma, Ohio, Michigan, Texas, New Jersey, and New York. Healthcare providers and facilities that received these devices should stop using them and contact Cook Inc. for further instructions.
The recalled product
- Product
- Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
- Manufacturer
- Cook Inc.
- Affected units
- 25
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 (1)
- Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304
Distribution
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