| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00016-1 |
| Product Name/Description |
RF-32#Centrifugal Pump with FLOWPROBE
Item number: 701005308
Serial Numbers: 3000284766, 3000330441, 3000356672, 3000358962
ARTG 145581
(Getinge Australia Pty Ltd - Circulatory assist unit, pump, centrifugal) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
MCP/Getinge discovered narrow channels in the seal of the sterile bags used to package the RF-32. MCP/Getinge receives this sterile bag from a supplier that performs tests to verify sterility. Incomplete sealing can potentially lead to a breach of the sterile barrier.
This hazardous situation could result in inflammation, infection or sepsis.
There have been no adverse events or customer complaints reported related to the issue described above. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine affected stock and return it to their Getinge Local Representative.
A credit note or replacement stock will be provided once the affected stock is returned.
If a product is already in use, Getinge is advising it should remain in use due to increased potential risk when disconnecting the product during ongoing therapy. |
| Contact Information |
1800 438 464 - Getinge Customer Service |