| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02230-1 |
| Product Name/Description |
Cocoon Respirator Masks
Regular size head band (MSK-002):
*All batches with expiry dates of May 2023 or prior.
Small size, ear loop (MSK-001S):
*All batches with expiry dates of June 2023 or prior.
ARTG 340518 (Care Essentials Pty Ltd - Surgical/medical respirator, single-use) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/02/2022 |
| Responsible Entity |
|
| Reason/Issue |
The TGA has undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).
Care Essentials Pty Ltd has supplied batches of Cocoon Respirator Masks (Surgical/medical respirators), which when tested by the TGA, samples of the device demonstrated inconsistent testing results for fluid resistance.
The TGA tested Batch N4-240521 (Model MSK-002), which showed fluid resistance inconsistencies at the location of the logo only and Batch NS2-210621 (Model MSK-001s), which showed fluid resistance inconsistencies at the location of the seam only.
All batches of Cocoon Respirator Masks Model MSK-002 with expiry dates of May 2023 or prior and all batches of Cocoon Respirator Masks Model MSK-001s with expiry dates of June 2023 or prior may be affected by inconsistent fluid resistance. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
The TGA does not require the face masks to be physically recalled (or otherwise removed) from the market. These facemasks can continue to be used in non-healthcare settings.
Additional protection via a face shield or visor should be considered if they are being used in high risk clinical or patient/caregiving scenarios where a level 3 fluid resistance barrier 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 reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
03-5277-1455 - Care Essentials Customer Service. |