Surgical, respirator, non-medical device (Ironbark creek investments)
Product Name
Surgical, respirator, non-medical device
Sponsor
ARTG
334588
Manufacturer
Jiangxi Zhongchen Keji Co Ltd
Type of market action
Recall
Reason
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.
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.
Additional information