US Endoscopy Group Inc recalls Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath dev…

Recall date

May 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0289-2017

FDA classification

Class II

Brand / firm

US Endoscopy Group Inc

Sold / distributed

US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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