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andorate® CO2 Extend Tubing with Luer Connector
GA Health Company Limited · Model GAR091 · UDI-DI 04897106950201
FCX
Prescription
1
510(k) clearances
540
Adverse events (6 deaths)
2
Recalls
33
Facilities
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.