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High Frequency Oscillatory Ventilators Models 3100A and 3100B (2013-03-11)
- Starting date:
- March 11, 2013
- Posting date:
- December 17, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37155
Recalled products
- High Frequency Oscillatory Ventilator Model 3100A (Cap Diaphragm)
- High Frequency Oscillatory Ventilator Model 3100B (Cap Diaphragm)
Reason
There have been reports of failures of Cap / Diaphragm assemblies. Specific lots of Cap / Diaphragm assemblies used with 3100A or 3100B high frequency oscillatory ventillators could fail thereby preventing the targeted mean airway pressure (39 - 43 cm H20) being reached during system calibration test set up prior to being used on patients.
Affected products
A. High Frequency Oscillatory Ventilator Model 3100A (Cap Diaphragm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 3100A
Companies
- Manufacturer
-
Carefusion
22745 Savi Ranch Parkway
Yorba Linda
92887
California
UNITED STATES
B. High Frequency Oscillatory Ventilator Model 3100B (Cap Diaphragm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 3100B
Companies
- Manufacturer
-
Carefusion
22745 Savi Ranch Parkway
Yorba Linda
92887
California
UNITED STATES