Recall Z-1943-2015
US Endoscopy Group Inc · initiated February 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
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.
FDA-determined cause: Under Investigation by firm
Action taken
US Endoscopy sent an Urgent Recall Notification Letter dated to their customers. The letter identified the affected product, problem and actions to be taken. US Endoscopy requests that their customers: 1. Remove all unused affected Velocity Biopsy Valves from your inventory. 2. Complete the attached Customer Response Card and return to the attention of Kia Pennington, via fax 1-440-639-4495 or email kpenning@usendoscopy.com. 3. Mark the shipping container with code: RMA xxxxxxxx QIF, and return the product to US Endoscopy via Fed Ex Account #293799547. For questions contact Kia Pennington in Customer Service at 1-800-769-8226.
Details
- Recall number
- Z-1943-2015
- Initiated
- February 17, 2015
- Posted by FDA
- July 1, 2015
- Terminated
- September 21, 2015
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Quantity
- 2,173 units
- Distribution
- 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.
- Recalling firm
- US Endoscopy Group Inc, Mentor, OH