Type of Product |
Medical Device |
TGA Recall Reference |
RC-2018-RN-00267-1 |
Product Name/Description |
Scalpel in Lifemed Procedure Packs
Component: IN1951
Multiple Product Codes and Lot Numbers
ARTG Numbers: 180554, 180555, 189114, 193043 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
20/04/2018 |
Responsible Entity |
|
Reason/Issue |
Product complaints received by Bard Australia reported that the safety sheath covering the scalpel blade (component number IN1951) was found in a very low number of Lifemed Procedure Packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.
This issue does not impact the sterility of the packs. |
Recall Action |
Product Defect Correction |
Recall Action Instructions |
Users are being made aware of this issue and asked to take extra care when opening the procedure packs. Affected units may be returned at the discretion of the customer on a case by case basis.
This action has been closed out on the 16/10/2018. |
Contact Information |
02 8875 4021 - Bard Australia |