| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01644-1 |
| Product Name/Description |
Nellcor RS10 SpO2 Forehead Sensor
Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H, 161970090H, 162040107H, 162110103H, 162320191H and 162390212H
ARTG Number: 182876 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is recalling specific item codes and production lots of the Covidien Nellcor RS10 SpO2 forehead sensor. This recall is being conducted due to a labelling error. The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. The sensor array itself is latex free. The use of products containing latex may result in allergic reactions for patients and providers who have latex sensitivity. Allergic reactions can include skin rash, itching, dyspnoea and anaphylaxis. There have been no reports of serious injury associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to quarantine and discontinue use of the affected item codes and lots. Also, immediately advise all surgeons/surgery personnel of this recall. Medtronic will be issuing credit for returned devices.
This action has been closed out on 25/09/2018 |
| Contact Information |
02 9429 3123 - Medtronic |