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PURITAN BENNETT 980 SERIES VENTILATOR (2015-07-20)
- Starting date:
- July 20, 2015
- Posting date:
- August 10, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54552
Affected Products
A. PURITAN BENNETT 980 SERIES VENTILATOR
Reason
The PB980 Universal Model Ventilator is designed for neonatal, pediatric and adult patients. This action is being taken in response to reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (VC+) mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Affected products
A. PURITAN BENNETT 980 SERIES VENTILATOR
Lot or serial number
S/N: >10 CONTACT MFR
Model or catalog number
980U1ENDICU
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES