Bunnell Patient Circuits Recalled Due to Heater Wire Insulation Melting
Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator because heater wire insulation can melt, causing sparking and smoke.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a defect (melting insulation) that causes sparking and smoke, posing a significant risk of fire or injury to critically ill patients, which aligns with the 'Severe' criteria for significant injury/property-damage reports or structural defects.
Plain-English summary
Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator. These circuits are required disposable components used to ventilate critically ill infants with specific pulmonary conditions. The recall covers 5,743 patient circuits distributed in the United States, Canada, Australia, Malaysia, and Uruguay.
Customer complaints indicate that the heater wire insulation in the circuit can melt. This melting can cause a short circuit, resulting in sparking and smoke near the humidifier cartridge. The affected lots were distributed between March 12, 2012, and November 30, 2012.
Healthcare facilities and users should stop using the affected Patient Circuits immediately. Bunnell, Inc. is the recalling firm and is responsible for managing the recall of these specific catalog numbers and lot numbers.
The recalled product
- Product
- 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…
- Manufacturer
- Bunnell, Inc.
- Hazard
- Affected units
- 5,743
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 12C102
- 12C115
- 12C125
- 12C136
- 12D159
- 12D172
- 12D189
- 12E204
- 12E211
- 12E224
- 12F241
- 12F254
- 12F271
- 12G279
- 12G290
- 12G307
- 12G321
- 12H330
- 12H349
- 12I362
Distribution
Distributed nationwide across the United States.
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