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Ambu® SPUR® II Pediatric Resuscitator

Ambu A/S · Model 530213031 · UDI-DI 05707480152452

OEV Prescription

510(k) clearances

197

Adverse events (19 deaths)

Recalls

Facilities

Description

Single Patient Use Resuscitator

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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Data 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.