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O-Two
O-Two Medical Technologies Inc · Model 01CV8010 · UDI-DI 07540195005129
CAI
Prescription
10
510(k) clearances
2,347
Adverse events (11 deaths)
204
Recalls
201
Facilities
Description
The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve. The 01CV8010 is specifically designed for use on Bag-Valve-Mask resuscitators and ventilators without demand breathing or patient triggered ventilation modes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-12 | Medline Industries, LP | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi |
| 2026-05-28 | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th |
| 2026-05-28 | Medline Industries, LP | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm g |
| 2026-05-06 | Medline Industries, LP | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec |
| 2026-04-10 | Medline Industries, LP | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o |
| 2026-02-16 | Medline Industries, LP | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2025-12-24 | Medline Industries, LP | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on th |
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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.