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AirLife
Carefusion Corporation · Model 2K8021 · UDI-DI 10885403170331
OEV
Prescription
0
510(k) clearances
197
Adverse events (19 deaths)
36
Recalls
18
Facilities
Description
Infant Manual Resuscitator; Oxygen Resevoir bag, Infant Mask, Pressure Limiting Valve with lock
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.