Type of Product |
Medical Device |
TGA Recall Reference |
RC-2017-RN-00015-1 |
Product Name/Description |
Transpac 4 Disposable Pressure Transducer Monitoring Kit
Product Number: 989803177901 Lot Numbers: 3239500, 3247905
Product Number: 989803194641 Lot Number: 3258299
ARTG Number: 197576 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
6/01/2017 |
Responsible Entity |
|
Reason/Issue |
Certain lots of the Transpac 4 Disposable Pressure Transducer Monitoring Kit may have the potential to leak or potentially introduce small amounts of air into the line. This could result in potential harm to the patient due to blood loss, introduction of air into the line or contamination of intravenous fluid. There is also potential harm to the user as a result of exposure to blood borne pathogens. |
Recall Action |
Recall |
Recall Action Instructions |
Philips is advising users to discontinue use of affected products and to check their inventory for affected stock. Affected stock is to be quarantined and users are requested to contact Philips prior to returning the affected products in order to receive a credit. This action has been closed-out on 01/03/2018. |
Contact Information |
1800 251 400 - Philips Customer Care Centre |