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Type of Product Medical Device
TGA Recall Reference RC-2021-RN-02376-1
Product Name/Description Endeavour KN95 Mask

Public N95 respirator

Batch number: 20200402

Expiry date: 4/04/2022

ARTG 333428 - Cancelled by Secretary as of 11 January 2021
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/12/2021
Responsible Entity Zenpharm Pty Ltd
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).

Zenpharm Pty Ltd has supplied batch 20200402 of Endeavour KN95 Mask(s) which have shown failed testing results, specifically for Particulate Filtration Efficiency (PFE), which measures the efficiency of the respirator to filter fine particles from inspired air.

Respirators which perform below the claimed level of PFE will not afford their wearers the expected level of protection when used in an environment where respiratory protection is required.

Following cancellation of this ARTG entry, the sponsor has also not provided any relevant supply information, including a list of their customers to whom these face masks may have been distributed.
Recall Action Recall
Recall Action Instructions For users who are operating in environments where a P2 respirator or equivalent respirator (e.g. N95 or >95%PFE) is recommended or required, including areas when protection is required to minimise exposure to bushfire smoke/ poor air quality and associated health effects, an alternative product that offers the expected level of respiratory protection should be used.

Customers should:
- Quarantine and destroy any affected product
- Cease use of the product in areas where 95% particulate filtration efficiency is required.

It is at the user’s discretion to determine if these products should or could be re-deployed depending on where they are currently being used.

This action has been closed out on 13/01/2022
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