Cook Inc. Recalls Amplatz Extra Stiff Whisker Wire Guide for Labeling Error
Cook Inc. is recalling 648 Amplatz Extra Stiff Whisker 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, but the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Cook Inc. is recalling 648 units of the Amplatz Extra Stiff Whisker Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated. This labeling omission may affect clinical decision-making regarding the use of the device.
The affected products are identified by Catalog # THSCF-35-260-3-AESW-BH. The affected lot codes range from 3733552 to 6175191, F3729974 to F4923948, and NS4927345 to NS6177894. The products were distributed nationally.
Healthcare providers and facilities should check their inventory for these specific lot codes and discontinue use of the affected units. Consumers should contact their healthcare provider if they have questions regarding this recall.
The recalled product
- Product
- Amplatz Extra Stiff Whisker Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 648
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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