Cardiopulmonary Resuscitation Aid Kit
Anesthesiology · 21 CFR 868.5915
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
197 adverse event reports on file
- SPUR II Adult PLV Md FM Filter Mano PEEP ValveJul 31, 2026InjuryAmbu A/s9610691-2026-00025
- SPUR II Adult PLV Md FM Filter Mano PEEP ValveJul 31, 2026InjuryAmbu Inc.1220828-2026-00025
- SPUR IIJun 22, 2026MalfunctionAmbu A/s9610691-2026-00019
- SPUR IIJun 22, 2026MalfunctionAmbu A/s1220828-2026-00019
- AMBU® SPUR® IIJun 19, 2026DeathAmbu A/s9610691-2026-00017
- AMBU SPUR IIJun 19, 2026DeathAmbu A/s1220828-2026-00018
- AMBU MARK IV; AMBU SPUR IIMay 27, 2026MalfunctionAmbu A/sMW5188660
- AMBU® SPUR® IIMay 22, 2026MalfunctionAmbu A/s9610691-2026-00014
- AMBU® SPUR® IIMay 22, 2026MalfunctionAmbu A/s1220828-2026-00014
- SPUR II INFANT OPEN RES.May 21, 2026InjuryAmbu A/s9610691-2026-00013
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Failure to Disconnect”
No history to chart.
Recalls
36 recall events for this product code
- Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1547-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1548-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1549-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1550-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1551-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1552-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1553-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1554-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1555-2018 · View FDA record ↗ - Vyaire MedicalTerminatedMay 10, 2018
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer
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/unable to disconnect condition of the mask from the elbow of the resuscitator.
Z-1556-2018 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Isomedix Operations Inc
El Paso, TX, US
Galemed (xiamen) Co., Ltd.
XIAMEN Fujian, CN
Isomedix Operations Inc
EL PASO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Bound Tree Medical, Llc
Grand Prairie, TX, US
Ambu Limited
XIANG YU F.T.Z., XIAMEN Fujian, CN
Ambu Mexico Operations S.a. De C.v.
Ciudad Juarez Chihuahua, MX
Medline Industries, Lp - Northfield
Northfield, IL, US
Ambu A/s
Ballerup Hovedstaden, DK
Xiamen Compower Medical Tech. Co., Ltd.
Xiamen Fujian, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Marken Healthtech Limited
NASHIK Maharashtra, IN
Mark Enterprises
Nashik Maharashtra, IN
Cardinal Health 200, Llc
El Paso, TX, US
Chinook Medical Gear, Inc.
Tulsa, OK, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.