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US Endoscopy · Model 710603 · UDI-DI 00816765013168
FCX
Prescription
1
510(k) clearances
551
Adverse events (6 deaths)
2
Recalls
33
Facilities
Description
The High Pressure Hose and Yoke for CO2 for use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with standard yoke connectors.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-15 | Northgate Technologies, Inc. | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| 2013-09-16 | Pentax Medical Company | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an end |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.