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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00215-1
Product Name/Description Head Positioning Devices

Product code: EVS-PBHP00001

Lot number: 0021351

ARTG Number: 177472
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/03/2014
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue Envisen have discovered the lot number 0021351 was not aerated for the recommended amount of time after manufacturing, and is emitting an undesirable smell. The smell has been identified as Polyether polyol and Triethylene diamine. Contact with or inhalation of Triethylene diamine can pose a safety risk to patients.
Recall Action Recall
Recall Action Instructions Device Technologies are requesting users to isolate affected stock from use. Affected stock can be returned to Device Technologies for credit.
Contact Information 1800 429 551 - Device Technologies Australia Pty Ltd