US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect
US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could cause component separation during use, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
US Endoscopy Group Inc is recalling 2,173 units of the Velocity Biopsy Valve, a disposable medical device used to cover the biopsy inlet port of flexible gastrointestinal endoscopes. The recall involves specific lots of the product, including 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
The company initiated the recall after receiving reports of structural non-conformance at the connection between the valve body and the irrigation tube. This defect can result in the separation of the components during use. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including in the United States (CA, CO, IA, MA, OH, TX, and WV) and in countries such as Brazil, France, Germany, and India. Healthcare facilities and users should stop using the affected units and contact US Endoscopy Group Inc for further instructions.
The recalled product
- 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,
- Manufacturer
- US Endoscopy Group Inc
- Affected units
- 2,173
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- M/N: 00711140
- Lot #'s: 1401267
- 1404503
- 1408953
- 1413362
- 1417521
- 1420739
- 1422288
- 1422747
- 1424014
- and 1500443.
Distribution
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