Z-1943-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- February 17, 2015
- Termination Date
- September 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,173 units
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.
Code Information
M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.