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AirLife Isothermal Breathing Circuit Products
- Starting date:
- June 20, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16325
Recalled Products
- AirLife Isothermal Breathing Circuit Accessory- Infant Patient Connector
- AirLife Isothermal Breathing Circuit Infant Respiratory Circuit (Heated or Non-Heated)
- AirLife Isothermal Breathing Circuit Infant Respiratory Circuit Heated
- AirLife Isothermal Breathing Circuit Infant Respiratory Circuit MR850
Reason
The y adapter within the circuit may spontaneously crack causing a leak in the closed ventilation system, the leak may cause a loss of tidal volume being delivered to the patient and the ventilator alarm may sound. The leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Affected products
A. AirLife Isothermal Breathing Circuit Accessory- Infant Patient Connector
Lot or serial number
All less than Lot #000415257 or
All starting with the letter Y
Model or catalog number
5925-504
Companies
- Manufacturer
-
carefusion
B. AirLife Isothermal Breathing Circuit Infant Respiratory Circuit (Heated or Non-Heated)
Lot or serial number
All less than Lot #000415257 or
All starting with the letter Y
Model or catalog number
More than 10 Numbers, contact manufacturer
Companies
- Manufacturer
-
carefusion
C. AirLife Isothermal Breathing Circuit Infant Respiratory Circuit Heated
Lot or serial number
All less than Lot #000415257 or
All starting with the letter Y
Model or catalog number
1815-409
Companies
- Manufacturer
-
carefusion
D. AirLife Isothermal Breathing Circuit Infant Respiratory Circuit MR850
Lot or serial number
All less than Lot #000415257 or
All starting with the letter Y
Model or catalog number
RT4851-00, RT4851-12, RT4851-18
Companies
- Manufacturer
-
carefusion