| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01126-1 |
| Product Name/Description |
Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)
Catalogue Number: 611637201
Product reference: 12003-000-0015
List Number: 16372A9601
Batch Numbers: 0167000814, 0167001414, 0167001514, 0167001914 and 0167002414
ARTG Number: 200689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
QCore Medical, the manufacturer of Sapphire Administration IV set AP424 has become aware of an increased incidence in specific batches of sets leaking in the sleeve areas (the adapter that connects between the tube and other components). The infusion set leaks may potentially result in under-dose or allergic reaction (in case the set is leaking and the drug comes into contact with the patient or healthcare professional) or increased risk of infection. The likelihood of harm will depend on the patient’s circumstances, such as the severity of their illness, the healthcare setting and the criticality of the infusion. QCore Medical is not aware of any report of injury attributed to this defect. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is requesting the users to check the AP24 set for leaks at the start of administration and to follow the instructions for use included with the Administration Sets and with the Sapphire Infusion Pump. New sets, without the defect should be available in mid November. This action has been closed-out on 01/03/2016. |
| Contact Information |
1300 046 774 (Option 1) - Hospira Customer Service |