Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the openi
FDA device recall Z-1943-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OCX
- Quantity affected
- 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,
- Date initiated
- 2015-02-17
- Date posted
- 2015-07-01
- Date terminated
- 2015-09-21
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 (K092461) | United States Endoscopy Group, Inc. | 2009-11-05 |