Cook Inc. Recalls Amplatz Ultra Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 12,462 Amplatz Ultra Stiff Wire Guides because the label fails 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, but the source text identifies the issue as a labeling error without reporting any illnesses or injuries. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported harm fall under Moderate severity.
Plain-English summary
Cook Inc. is recalling 12,462 units of the Amplatz Ultra Stiff Wire Guide, catalog numbers THSF and ASG-BH. The recall is due to a labeling error where the product label does not state that the device is heparin-coated.
The affected lot codes range from 3730001 to 6164916, F3729969 to F4922979, and NS4928020 to NS6203182, as well as 3733552 to 6175191, F3729974 to F4923948, and NS4927345 to NS6177894. The products were distributed nationally.
Healthcare providers should check their inventory for these specific lot codes and stop using the affected devices. Consumers are not typically the end-users of this medical device, but patients who have received this device should consult their healthcare provider regarding the labeling discrepancy.
The recalled product
- Product
- Amplatz Ultra Stiff Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 12,462
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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