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O-Two
O-Two Medical Technologies Inc · Model 02RT1040 · UDI-DI 07540195070202
BYG
Prescription
10
510(k) clearances
470
Adverse events (9 deaths)
41
Recalls
269
Facilities
Description
The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-21 | Medline Industries, LP | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortnes |
| 2018-07-11 | POM Medical LLC | Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port. |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc |
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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.