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AirLife
Carefusion Corporation · Model 2K7006 · UDI-DI 10885403220517
OEV
Prescription
0
510(k) clearances
197
Adverse events (19 deaths)
36
Recalls
18
Facilities
Description
Adult Manual Resuscitator, Oxygen Reservoir Bag, Medium Adult Mask, Pressure Limiting Valve with Lock, Expiratory Filter,Pressure Manometer, 7' O2 Tubing
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-19 | ROi CPS LLC | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
| 2017-04-27 | Vyaire Medical | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab |
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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.