Cook Inc. Recalls Coons Interventional Wire Guide Due to Labeling Error
Cook Inc. is recalling 3,369 Coons Interventional Wire Guides 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: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding heparin coating, which fits the criteria for moderate severity involving labeling issues.
Plain-English summary
Cook Inc. is recalling 3,369 units of the Coons Interventional Wire Guide. 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 involves catalog number THSF-/-COONS-BH with lot codes ranging from 3730001 to 6164916, F3729969 to F4922979, and NS4928020 to NS6203182.
Healthcare providers should check their inventory for these specific lot codes and stop using the affected devices. They should contact Cook Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Coons Interventional Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 3,369
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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