Patient Circuit used with the Life Pulse High Frequency recall
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High…
Why was Patient Circuit used with the Life Pulse High Frequency 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High…
- Recalling firm
- Bunnell, Inc.
- Quantity
- 5743 patient circuits distributed in commerce
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
- Recall date
- December 26, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)