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Health product recall

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

  1. AirLife Isothermal Breathing Circuit Accessory- Infant Patient Connector
  2. AirLife Isothermal Breathing Circuit Infant Respiratory Circuit (Heated or Non-Heated)
  3. AirLife Isothermal Breathing Circuit Infant Respiratory Circuit Heated
  4. 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