Cook Inc. Recalls Fixed Core Bentson Devices Due to Labeling Error
Cook Inc. is recalling 2,210 Fixed Core Bentson devices because the labels fail to state that the product is heparin-coated.
What this means for you
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 regarding heparin coating, which fits the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Cook Inc. is voluntarily recalling 2,210 units of the Fixed Core Bentson medical device. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected devices were distributed nationally. The specific catalog number is TSCFB-/-BH, and the affected lot numbers range from F3734676 to F4911986 and NS4938980 to NS6144078.
Healthcare providers and consumers should stop using these specific devices and contact Cook Inc. for further instructions or replacement.
The recalled product
- Product
- Fixed Core Bentson
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 2,210
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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