Cordis ADROIT 6F Guiding Catheter Recalled for Labeling Error
Cordis Corporation is recalling 1,238 units of ADROIT 6F Guiding Catheters due to a labeling error regarding the conversion of the inner diameter from inches to millimeters.
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 explicitly identifies the issue as a labeling error where the primary dimension is correct, fitting the rubric for minor labeling errors.
Plain-English summary
Cordis Corporation is recalling 1,238 units of the Cordis ADROIT 6F Guiding Catheter. These medical devices are used for the intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
The recall is due to a labeling error related to the conversion of the catheter's inner diameter from inches to millimeters. The source text notes that the English dimension is correct and is the primary dimension.
The affected products were distributed worldwide, including nationwide in the United States and in various countries across Europe, the Middle East, and Asia. The specific catalog numbers and lot numbers are listed in the structured product information. Consumers and healthcare providers should verify their inventory against the provided lot numbers and contact Cordis Corporation for further instructions.
The recalled product
- Product
- Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1,238
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 15892739 67205400 15885645
- 15887472
- 15887474
Distribution
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