Reported Jul 8, 2015 · Terminated
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the…
US Endoscopy Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Endoscopy Group Inc · 5976 Heisley Rd · Mentor, OH · 44060-1873
Is this the product you have?
- Velocity" Biopsy Valve, 25 units per box
- Product UsageThe 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
- Lot codes and dates
- M/N
00711140Lot #'s: 140126714045031408953141336214175211420739142228814227471424014and 1500443
- M/N
- Amount recalled
- 2,173 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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