Cook Inc. Recalls Bentson Plus Wire Guide Due to Labeling Error
Cook Inc. is recalling the Bentson Plus Wire Guide because the label fails 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: This is an FDA Class II recall involving a labeling error where the heparin coating is not stated on the label. Per the rubric, minor labeling errors and Class II classifications without reported illness or injury are categorized as Moderate severity.
Plain-English summary
Cook Inc. has initiated a recall of the Bentson Plus Wire Guide, with a total quantity of 8,147 units affected. The distribution pattern for these products is national.
The reason for this recall is that the product label does not state that the device is heparin-coated. This labeling omission constitutes the hazard associated with this recall action.
The recalled product
- Product
- Bentson Plus Wire Guide
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Wire Guide
- Hazard
- Affected units
- 8,147
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 # TSFBP- / -BH Affected lots include: 3771080 - 5942053 F4265639
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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