Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reported: April 9, 2025 Initiated: March 4, 2025 #Z-1510-2025
Product Description
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason for Recall
product mix-up; Vascular stent labeled as one size but contains a different size.
Details
- Recalling Firm
- Cordis US Corp
- Units Affected
- 20 units
- Distribution
- US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only. Recalled by Cordis US Corp. Units affected: 20 units.
Why was this product recalled? ▼
product mix-up; Vascular stent labeled as one size but contains a different size.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1510-2025.
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