FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects
The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect may lead to respiratory compromise, but the source text does not report any specific injuries, hospitalizations, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 657 units of the Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. The devices are manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.) and are designed for use on neonatal through adult patient populations requiring respiratory support or mechanical ventilation.
The recall was initiated due to reports where tidal volumes reaching patients were lower than the set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
The affected units were distributed worldwide, including the United States (nationwide), Canada, and numerous other countries. The specific model codes affected are 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS.
The recalled product
- Product
- Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
- Category
- Medical Device — Ventilator
- Affected units
- 657
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 (8)
- PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU
- 980U1ENDIUUS
- 980U3ENDIUU
- 980U3ENDIUUS
- 980N1ENDIUU
- 980N1ENDIUUS
- 980N3ENDIUU
- 980N3ENDIUUS
Distribution
Distributed nationwide across the United States.
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