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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01156-1
Product Name/Description Adult Circuit Tubing (Oxygen therapy delivery system)

Product Code: 900MR068

Lot Numbers: 110810 & 111020

ARTG Number: 129354
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/11/2012
Responsible Entity Fisher & Paykel Healthcare Pty Ltd
Reason/Issue Fisher and Paykel Healthcare has become aware that one batch of tubes supplied to Fisher and Paykel Healthcare may contain hole damage. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
Recall Action Recall
Recall Action Instructions Fisher and Paykel is recalling affected product and is replacing it with unaffected tubing.
Contact Information 1800 060 698 - Fisher & Paykel Healthcare