| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01237-1 |
| Product Name/Description |
Various Safeset and Transpac Blood Pressure Transducer Sets
Multiple Products, Item and Lot Numbers affected
ARTG Number: 195624 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
ICU Medical has identified a potential for detachment or separation of pressure tubing/luer bonded connections on specific Blood Pressure Tranducer Sets.
ICU Medical has received reports due to this issue and there is the potential for serious injury. As a precaution, ICU Medical is recalling the affected devices. |
| Recall Action |
Recall |
| Recall Action Instructions |
ICU Medical is advising users to inspect stock and quarantine all affected units. Any remaining affected stock will be returned and replaced or a credit note issued.
This action has been closed-out on 16/08/2018. |
| Contact Information |
8335 1010 - ICU Medical Customer Centre |