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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00429-1
Product Name/Description Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)

Model Number: 55-12-500

Serial Numbers: 1506-CC02-0039, 1506-CC02-0040

ARTG Number: 118226
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/04/2016
Responsible Entity Bosco Medical Australia
Reason/Issue The manufacturer has identified two issues relating to the power supply;

- That the two halves of the power supply may come apart. If the two halves are not properly closed, there is a low risk of injury by electricity. As the conductive parts are secured by a fuse, severe injury is prevented.
- The screw on domes for the housing of the power supply may break, and as a result, the housing itself may partially or completely come apart due to carious factors.

It cannot be ruled out that the two issues may coincide and there is a low risk of injury by electricity.

This action was undertaken prior to consultation with the Therapeutic Goods Administration (TGA).
Recall Action Recall
Recall Action Instructions Bosco has advised users to inspect power supply units for any defects. Any affected devices should be returned to Bosco for replacement with unaffected units. This action has been closed-out on 17/08/2016.
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