CareFusion EnVe Ventilator Recalled for PEEP Pressure Control Failure
CareFusion 203, Inc. is recalling 266 EnVe Ventilators because they may fail to hold set pressure values or alarm for circuit faults, potentially compromising patient ventilation.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP…"
Plain-English summary
CareFusion 203, Inc. is recalling 266 units of the CareFusion EnVe Ventilator. The device is designed for patients requiring respiratory support or mechanical ventilation who weigh at least 5 kg (11 lbs) and is used in hospital and transport environments.
The recall was initiated because the ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value intermittently or continuously, or it may alarm for a Patient Circuit Fault. While the unit activates audible and visual alarms to alert healthcare professionals, the source text states that ventilation delivery to the patient may be compromised.
The affected units were distributed nationwide, including in Arizona, California, Colorado, Florida, Illinois, Kentucky, Maine, Michigan, Missouri, Minnesota, Montana, North Dakota, New Jersey, New Mexico, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Wisconsin, and West Virginia. Specific serial numbers are listed in the agency's recall record.
The recalled product
- Product
- CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive…
- Manufacturer
- CareFusion 203, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 266
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)
- serial numbers: 26562
- 43634
- 43642
- 43643
- 44536
- 44537
- 44540
- 44541
- 44542
- 44543
- 44544
- 44545
- 44546
- 44552
- 44553
- 44554
- 44555
- 44557
- 44558
- 44559
Distribution
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