| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01335-1 |
| Product Name/Description |
Blood Pressure Monitoring Kits with Transpac IV Transducers
Kit - Royal Women Hospital QLD, Special Care Nursery (Item: 011-0J069-01, Lot: 3253136)
Kit - Neonatal/Childrens Australia (Item: 011-46103-16, Lot: 3263780)
Safeset Transpac IV (Item: 011-46103-25, Lot: 3207778)
Transpac IV (Item: 011-46104-49, Lot: 3242280)
Single Line Monitoring Kit w/Transpac IV (Item: 011-46104-52, Lot: 3253165)
Single Line Transpac IV Monitoring Kit (Item: 011-46107-16, Lot: 3235355)
ARTG Number: 195624 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that there is a potential for leaks with certain monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or introduce small amounts of air into the line. In a worst case, there is potential patient harm due to air embolism or contamination. ICU Medical, Inc. has not received any reports of adverse events associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
ICU Medical is advising customers to arrange for their stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 24/05/2017. |
| Contact Information |
02 9629 6977 - ICU Medical |