Cook Inc. Recalls Bentson Cerebral Wire Guide Due to Labeling Error
Cook Inc. is recalling 45 Bentson Cerebral 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 involves a labeling error (failure to disclose heparin coating) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Cook Inc. is recalling 45 units of the Bentson Cerebral Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected units were distributed nationally. The specific catalog number is THSFB-35-145-BH, and the affected lots include F3813488 through F4859795 and NS5327890 through NS6060291.
Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices if found. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bentson Cerebral Wire Guide
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 45
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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