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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Bunnell, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0514-2013
Related Recalls
Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.