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U.S. Department of Health and Human Services

Class 2 Device Recall Velocity Biopsy Valve

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  Class 2 Device Recall Velocity Biopsy Valve see related information
Date Initiated by Firm February 17, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-1943-2015
Recall Event ID 71336
510(K)Number K092461  
Product Classification endoscopic irrigation/suction system - Product Code OCX
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.
Code Information M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
Recalling Firm/
US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Mrs. Kia Pennington,
Manufacturer 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 2
Under Investigation by firm
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCX and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.