| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01228-1 |
| Product Name/Description |
Spinocath G22 / G27 (Spinal anaesthesia kit)
Article Number: 4517725
All batches affected
ARTG Number: 148912 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
During internal quality checks B. Braun discovered that the certain Spinocath articles may have holes in the PVC film of the sterile barrier system. There is a risk that microorganisms may penetrate the sterile barrier through the holes in the PVC barrier. Thus, contamination is possible and may pose a risk to the patient. The risk of a clinically significant infection has been assessed as low but cannot be excluded. To date no harm or any other adverse patient outcome associated with this issue has been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
B. Braun is advising users to inspect stocks and destroy all units from the affected article code. Credit will be provided for all unused/destroyed stock. Records of previous patients should be reviewed and any potentially related infections reported to B. Braun.
This action has been closed out on 08/11/2018 |
| Contact Information |
1800 172 182 - B.Braun Recall co-ordinator |