| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00283-1 |
| Product Name/Description |
Aerowound Combine Dressing ACD2040S, size 20cm x 40cm
Batch Number: 17110
Expiry Date: 31 August 2021
ARTG Number: 159437 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
The Aerowound Combine Dressing is comprised of an absorbent pad enclosed in a polyester/viscose over bag. Each sterile dressing is sealed in an individual pouch. It was discovered that one of the pouch edges has a weak sealing strength which could compromise the sterility of the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Aero Healthcare is advising customers to quarantine all affected stock within their control. Distributors are advised to forward the recall notice to retailers to whom they have sold affected products and to accept the affected stock returned to them. Distributors are further requested to contact Aero Healthcare to organise their return.
This action has been closed out on the 11/09/2018 |
| Contact Information |
1800 628 881 - Aero Healthcare |