International Medical Devices Database

Manufacturer Address
Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami FL 33186
Source
USFDA
2 Events
- Recall of Device Recall SCIPRO
- Recall of Device Recall SCIPRO

2 devices in the database

Device Recall SCIPRO

Model / Serial
Lot Number OML30522-01
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
The software systems were installed at 2 medical centers in Illinois and Alabama.
Product Description
The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.

Device Recall SCIPRO

Model / Serial
Lot # OML30403-01
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.
Product Description
SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Scion Cardio-Vascular, Inc.

2 devices in the database

Device Recall SCIPRO

Device Recall SCIPRO