Nellcor Puritan Bennett, Inc.
United StatesFDA applicant, unverified
- Devices
- 44
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Nellcor Puritan Bennett, Inc. makes
Nellcor Puritan Bennett manufactures tracheostomy tubes, pulse oximeters, and oximetry sensors for monitoring oxygen saturation, including adhesive forehead reflectance sensors. The company also produces ventilators for mechanical respiratory support, including models with integrated report generators and specialized pressure-support features. Patient monitoring systems with ECG and SpO₂ capabilities are part of its portfolio, alongside display and printer units for clinical data output.
The company’s devices are regulated under FDA Class II and Class III classifications, with some authorised via the 510(k) pathway and others through the Premarket Approval (PMA) process. Products are listed in the FDA’s 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 44 devicesFDA recalls
FDA recall records list 11 recalls initiated by Nellcor Puritan Bennett, Inc., the earliest on 2004-07-08 and the most recent on 2007-03-12. By recorded status: 11 terminated. The reasons filed fall into these groups: sterility or contamination, electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 12 Mar 2007 Z-0760-2007 Unclassified (pre-2012) Terminated In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.
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- 12 Mar 2007 Z-0760-2007 Unclassified (pre-2012) Terminated In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.
2006
- 12 Jul 2006 Z-1431-06 Unclassified (pre-2012) Terminated Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.
2004
- 17 Dec 2004 Z-0445-05 Unclassified (pre-2012) Terminated Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
- 16 Dec 2004 Z-0444-05 Unclassified (pre-2012) Terminated Wires on battery may loosen causing disconnection.
- 9 Dec 2004 Z-0721-05 Unclassified (pre-2012) Terminated Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
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- 18 Oct 2004 Z-0662-05 Unclassified (pre-2012) Terminated The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
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- 18 Oct 2004 Z-0663-05 Unclassified (pre-2012) Terminated The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
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- 18 Oct 2004 Z-0664-05 Unclassified (pre-2012) Terminated The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
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- 18 Oct 2004 Z-0665-05 Unclassified (pre-2012) Terminated The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
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- 24 Aug 2004 Z-1414-04 Unclassified (pre-2012) Terminated The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
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Show all 11 recalls
2004
- 8 Jul 2004 Z-1312-04 Unclassified (pre-2012) Terminated Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
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- 8 Jul 2004 Z-1312-04 Unclassified (pre-2012) Terminated Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
Frequently asked questions
How many devices does Nellcor Puritan Bennett, Inc. have in the registry?
The registry currently lists 44 devices for Nellcor Puritan Bennett, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nellcor Puritan Bennett, Inc.'s devices?
Among its 44 most recently registered devices, Nellcor Puritan Bennett, Inc. has devices listed in FDA 510(k) (43 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nellcor Puritan Bennett, Inc.'s devices fall under?
Among its 44 most recently registered devices, the classes recorded for Nellcor Puritan Bennett, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Nellcor Puritan Bennett, Inc.?
FDA recall records list 11 recalls initiated by Nellcor Puritan Bennett, Inc., the most recent initiated on 2007-03-12. 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 Nellcor Puritan Bennett, Inc. in the registry?
The most recently registered devices listed for Nellcor Puritan Bennett, Inc. include SHILEY FLEXTRA TRACHEOSTOMY TUBE, NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER, NPB-290 PULSE OXIMETER (NPB-290) and NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P.