Recall Z-1943-2015— US Endoscopy Group Inc

Name: FDA recall Z-1943-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-17

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2015-02-17, terminated 2015-09-21. It names one FDA 510(k) clearance: K092461. Product: Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.. Reason: The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Terminated: 2015-09-21
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K092461 — IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140United States Endoscopy Group, Inc.·cleared 2009-11-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

Reason for recall

The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.