CLASS I Device recall · Reported 26 Dec 2012 · FDA Enforcement Report
Patient Circuit used with the Life Pulse High Frequency Ventilator recalled
Bunnell is recalling Patient Circuit used with the Life Pulse High Frequency Ventilator, distributed nationwide in the US. The recall was initiated on 19 Nov 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0514-2013
- FDA event ID
- 63710
- Recalling firm
- Bunnell, Salt Lake City, UT
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Nov 2012
- FDA classified
- 14 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 19 Nov 2012 | Recall initiated by company | |
| 14 Dec 2012 | Classified by FDA | +25 days |
| 26 Dec 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
Questions about this recall
Is Patient Circuit used with the Life Pulse High Frequency Ventilator recalled?
Yes. Bunnell recalled Patient Circuit used with the Life Pulse High Frequency Ventilator on 19 Nov 2012. The recall is Class I and its status is Terminated. Recall number Z-0514-2013.
Why was it recalled?
Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.
Which lots are affected?
Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot # on the label on outside of box: 12C099, 12C114, 12C124, 12C135, 12D152, 12D170, 12D188, 12E203, 12E210, 12E223, 12F238, 12F255, 12F274, 12G209, 12G280, 12H334, 12H341, 12I356, 12I369, 12I392, 12J411, 12J425, 12J447, 12K467, 12K479
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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