Cook Inc. Recalls Amplatz Extra Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 129,727 Amplatz Extra Stiff 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, but the source text identifies the issue as a labeling omission regarding heparin coating without reporting any illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Cook Inc. is recalling 129,727 units of the Amplatz Extra Stiff 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 covers specific catalog numbers (THSCF / AES-BH and THSF / AES-BH) and lot codes ranging from 3730001 to 6164916, F3729969 to F4922979, NS4928020 to NS6203182, 3733552 to 6175191, F3729974 to F4923948, and NS4927345 to NS6177894.
Healthcare providers and patients should check their inventory and records for these specific lot codes. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.
The recalled product
- Product
- Amplatz Extra Stiff Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 129,727
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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