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US Endoscopy Group Inc recalls Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath d
Recalled October 26, 2016 · FDA recall Z-0289-2017 · US Endoscopy Group
Hazard
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products. · FDA Class II
Units
36 units
Sold at
US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Description
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
Product
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(s)
US Endoscopy Group Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →