Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-01500-1 |
Product Name/Description |
Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)
Lot Number: 956-522RW55
ARTG Number: 135319 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
16/11/2016 |
Responsible Entity |
|
Reason/Issue |
Radiometer has recently become aware of a potential issue with the Pico 70 Arterial Blood Sampler, 956-522 of Lot RW-55. It has been reported overseas that some needles seem to be corroded. The use of an arterial blood sampler contaminated with rust particles could lead to blood stream infection and organ damage. To date, no incidences have been reported in Australia. |
Recall Action |
Recall |
Recall Action Instructions |
Radiometer is requesting customers to quarantine stock from lot 956-522RW55. Radiometer will arrange for the collection of the affected product and replacement of this stock. Patients that have been exposed to the affected lot of Pico 70 Arterial blood sampler should be closely monitored for signs of infection or other adverse events. This action has been closed-out on 28/02/2018. |
Contact Information |
1800 247 254 - Radiometer |