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O-Two
O-Two Medical Technologies Inc · Model 02RT1010 · UDI-DI 07540195071308
CAT
Prescription
10
510(k) clearances
1,767
Adverse events (30 deaths)
6
Recalls
263
Facilities
Description
The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong and a thin tube.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2017-05-09 | Teleflex Medical | Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. |
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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.