Cook Inc. Recalls Reuter Tip Deflecting Wire Guide for Labeling Error
Cook Inc. is recalling 55 Reuter Tip Deflecting 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 and involves a labeling error regarding heparin coating. This aligns with the rubric for moderate severity, as it is a labeling issue without reported injuries or deaths.
Plain-English summary
Cook Inc. is recalling 55 units of the Reuter Tip Deflecting 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 specific catalog number is TDW-/-SGH-BH, and the affected lots include F4423853 through F4898351 and NS5072022 through NS6166764.
Healthcare providers and consumers should check their inventory for these specific lot numbers and contact Cook Inc. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Reuter Tip Deflecting Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 55
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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