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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00705-3
Product Name/Description Portapres NiMh battery pack (Device to continuously measure blood pressure)

Batch number: 12 02 010, 12 02 011, 12 02 003
ARTG: 138530
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/07/2012
Responsible Entity Ptronik Pty Ltd
Reason/Issue Due to a production error the battery packs may become hot and start leaking when exposed to mechanical stress.

This recall action was not notified to the TGA before it was initiated by Ptronik.
Recall Action Recall
Recall Action Instructions The sponsor is providing work around instructions and replacing all affected battery packs.
Contact Information 02 4578 9611 - Ptronik Regulatory Affairs