Ventlab Corp.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000008625
- Devices
- 1,051
- Registrations
- EUDAMED
- FDA recalls
- 21
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
What Ventlab Corp. makes
Ventlab Corp. manufactures single-use manual pulmonary resuscitators, anaesthesia face masks, and anaesthesia breathing circuits. The company also produces non-ventilatory atomizers, non-powered airway pressure monitors, exhaled-gas oesophageal intubation detectors, single-use microbial medical gas filters, and basic nasal oxygen cannulas.
The company is based in the United States, and its portfolio consists of Class I and Class II medical devices. These products are listed within the FDA UDI database.
Catalogue
Search and filter all 1,051 devicesShowing 1-50 of 1,051
Company details
- EUDAMED SRN
- US-MF-000008625
- EUDAMED status
- Active
- EUDAMED registered name
- Ventlab, LLC
- Registered address
- 2710 Northridge Dr. NW, Suite A, 49544, Grand Rapids, United States
- Website
- myairlife.com
- Phone
- +1-269-873-0502
- PRRC contact
- Robert Yamashita
FDA recalls
FDA recall records list 21 recalls initiated by Ventlab Corp., the earliest on 2003-04-15 and the most recent on 2016-03-15. By recorded status: 21 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 15 Mar 2016 Z-1880-2016 Class II Terminated Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
2014
- 16 May 2014 Z-1948-2014 Class I Terminated The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
2012
- 11 Jul 2012 Z-0170-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0171-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0172-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0173-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0174-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0175-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0176-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0177-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Show all 21 recalls
2012
- 11 Jul 2012 Z-0178-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0179-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0180-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- 11 Jul 2012 Z-0181-2013 Class I Terminated Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
2007
- 5 Dec 2007 Z-2324-2008 Unclassified (pre-2012) Terminated During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
2004
- 26 Mar 2004 Z-0891-04 Unclassified (pre-2012) Terminated In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- 26 Mar 2004 Z-0892-04 Unclassified (pre-2012) Terminated In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- 26 Mar 2004 Z-0893-04 Unclassified (pre-2012) Terminated In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- 26 Mar 2004 Z-0894-04 Unclassified (pre-2012) Terminated In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- 26 Mar 2004 Z-0895-04 Unclassified (pre-2012) Terminated In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
2003
- 15 Apr 2003 Z-0982-03 Unclassified (pre-2012) Terminated Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
Frequently asked questions
How many devices does Ventlab Corp. have in the registry?
The registry currently lists 1051 devices for Ventlab Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ventlab Corp.'s devices?
Among its 50 most recently registered devices, Ventlab Corp. has devices listed in EUDAMED (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ventlab Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ventlab Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ventlab Corp.?
FDA recall records list 21 recalls initiated by Ventlab Corp., the most recent initiated on 15 Mar 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ventlab Corp. in the registry?
The most recently registered devices listed for Ventlab Corp. include Ventlab BreatheRite™ Anti-Static Collapsible VHC, with Economy Spacer Mask Infant, Airlife AF5140MBPM5, Airlife AF5140MBM5 and Airlife AF5140MB-PWM5.