Devices

Device Recall VariSafe

Model / Serial
Model #: 00711819; Lot 1520268
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Product Description
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 || A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Manufacturer
US Endoscopy Group Inc
1 Event
- Recall of Device Recall VariSafe

Manufacturer

US Endoscopy Group Inc

Manufacturer Address
US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
Manufacturer Parent Company (2017)
Steris Plc
Source
USFDA

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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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