| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01184-1 |
| Product Name/Description |
Opti-Mist Nebuliser / Nebuliser Mask Products
Opti-Mist Nebuliser Kit 210cm Tmouth 50
Opti-Mist + Nebuliser 210cm T/Mouth10/50
Opti-Mist + Nebuliser 210cm admask 10/50
Opti-Mist + Nebuliser Ped Kit (5X10)
Opti-Mist + CS Fits-A 210cm(10/20)
Opti-Mist Plus Nebuliser Only (10/50)
Opti-Mist CL Nebuliser Kit (50)
Product Codes: PMD02600, PMD02601, PMD02602, PMD02603, PMD02604, PMD02605, PMD02606
Multiple Lot Numbers
ARTG Number: 214820 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Specific batches of Nebuliser mask products are not meeting specification. An error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. No or poor misting would impact the delivery of aerosolised liquids to the patient, which has the potential to result in harm if used with this defect. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising users to inspect and quarantine any affected stock for return to Thermo Fisher. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 8817 4279 - Thermo Fisher |