| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01273-1 |
| Product Name/Description |
KN95 respirators supplied by Ironbark Creek Investments
Product names (as shown on packaging / labelling):
* Medilogic KN95 Face mask.
* CX9100 Particulate Mask FFP2 NR.
* Medilogic KN95 Face mask Box 10.
* Zhongchen KN95 Face Mask.
* Zhongchen KN95 Face Mask Non-Surgical.
* YiHuB KN95 Protective Mask.
All batches of the above respirators within expiry.
ARTGs 334107, 334588, and 336086 - Cancelled from the Register |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2022 |
| Responsible Entity |
|
| Reason/Issue |
The Therapeutic Goods Administration (TGA) has undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).
TGA Laboratories have conducted testing for Particulate Filtration Efficiency (PFE) on several samples of Respirators previously included in the ARTG in relation to Ironbark Creek Investments.
TGA testing has identified that samples of the Respirators supplied under these ARTG entries did not comply with PFE requirements for respirators, along with a lack of homogeneity in the batches due to intra-batch variations.
The TGA’s testing results of several samples has also been confirmed by independent, third-party laboratory testing which also found that samples of the Respirators tested did not comply with PFE requirements for respirators.
This recall was initiated by the TGA in accordance with s.41KA of the Therapeutic Goods Act 1989 (the Act) and is being published in accordance with s.41KB of the Act. |
| Recall Action |
Recall |
| Recall Action Instructions |
Instructions For Users:
• Immediately quarantine all affected stock on hand and discontinue use.
• Please contact Ironbark Creek Investments immediately, advising the quantity of remaining stock in your possession.
• Ironbark Creek Investments will organise the return of impacted stock.
• Please forward the Recall notice to any individual or organisation you may have on-sold or distributed the impacted stock to.
This action has been closed out on 02/02/2024 |
| Contact Information |
1300 111 250 - Ironbark Creek Investments (Trading as Medilogic) |