Cook Inc. Recalls Amplatz Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 32,340 Amplatz Stiff Wire Guides 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, but the source text identifies the issue as a labeling omission regarding heparin coating without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Cook Inc. is recalling 32,340 units of the Amplatz Stiff Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected products were distributed nationally. The recall covers catalog numbers THSF and ASG-BH. Affected lot codes range from 3730001 to 6164916, F3729969 to F4922979, and NS4928020 to NS6203182.
Healthcare providers and facilities should check their inventory for these specific lot codes and stop using the affected devices. They should contact Cook Inc. for instructions on how to return the product.
The recalled product
- Product
- Amplatz Stiff Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 32,340
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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