| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01433-1 |
| Product Name/Description |
SURGICAL GOWN UL HP L
(Molnlycke Health Care Pty Ltd - Gown, operating room, single use)
Product number: 6901021-01
Batch number: 17357759
ARTG number: 138941 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
During internal rigorous quality checking, Mölnlycke has self-identified a quality issue with specific batches of gowns released between October 6th till October 16th 2017. The issue is regarding foreign particles (loose threads) being identified on the products.
No complaints or reports of patient harm related to this issue have been received as of November 2017. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to;
1. Identify and isolate all affected, BARRIER Ultimate Surgical Gown at your facility;
2. Complete the confirmation form supplied with the customer letter and e-mail/fax back per its instructions. Even if you no longer have any concerned BARRIER Ultimate Surgical Gown, Mölnlycke needs to be sure all customers are aware of the situation;
3. Mölnlycke will contact you and arrange for collection of the product(s) from your facility, as soon as you return the confirmation form. Mölnlycke will organize to issue a credit for the goods returned; and
4. If you have forwarded any affected products to other healthcare institutions, send them a copy of the customer letter together and make sure they act accordingly.
This action has been closed on the 14/09/2018 |
| Contact Information |
1800 005 231 - Molnlycke ANZ Customer |