Cook Inc. Recalls Bentson Wire Guides Due to Missing Heparin Labeling
Cook Inc. is recalling Bentson Wire Guides because the labels fail to state that the product is heparin-coated.
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 source text identifies a labeling error without reporting specific injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Cook Inc. is recalling 439,797 units of Bentson Wire Guides. The recall is due to a labeling error where the product label does not state that the device is heparin-coated.
The affected products were distributed nationally. The recall covers specific catalog numbers and lot ranges, including TSFB-/-BH with lots F3813488 through F4859795, NS5327890 through NS6060291, 3730884 through 5984142, F3746894 through F4920488, and NS4937520 through NS6252870.
Healthcare providers and patients should check their inventory or medical records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or supplier according to their instructions.
The recalled product
- Product
- Bentson Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 439,797
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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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