Type of Product |
Medical Device |
TGA Recall Reference |
RC-2017-RN-00758-1 |
Product Name/Description |
Caliber Inflation Device
Product Code: CL3030
Lot Numbers: 15045606, 15055430, 15065858, 15075121, 15075411, 15075821 and 15085378
ARTG Number: 174371 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
13/06/2017 |
Responsible Entity |
|
Reason/Issue |
The manufacturer, Perouse Medical has identified that specific product code / lot number combinations of the Caliber Inflation Device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier. For a cracked package, there is the risk of microbial contamination (infection) caused by the use of a product. Sterility would not be preserved due to a primary packaging damage. |
Recall Action |
Recall |
Recall Action Instructions |
Bard is advising users to immediately examine their inventory, and quarantine and remove product subject to this recall from their shelves. Do not use or further distribute any affected product. Product is to be returned by either handing to the user's Bard Territory Manager or by contacting Bard Australia Customer Service who will arrange for the return of any affected product.
This action has been closed out on 09/08/2019 |
Contact Information |
02 8875 4021 - Bard Australia |