| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00646-1 |
| Product Name/Description |
Paratherm Heater Cooler Unit
ARTG Number: 278698
(Australian Blood Management Unit Trust - Cardiopulmonary bypass system heating/cooling unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Updated Instructions For Use (IFU) and cleaning guidelines for the Paratherm Heater Cooler Unit have been released.
There was a Safety Alert communicated in April 2017 which referenced the interim cleaning and disinfecting guidelines. During the last 12 months, validation efforts have been undertaken by the manufacturer Chalice Medical to support the use of a Hydrogen Peroxide based disinfection agent. This disinfection agent has been subject to review and subsequent inclusion in the Australian Register of Therapeutic Goods (Amity HP 75, ARTG 302115, supplied by Lovell Surgical Supplies International as the Local Sponsor). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Amity HP 75 is to be made commercially available in Australia in June 2018. Stock is currently being manufactured and shipped to Australia. Once available in Australia, Australian Blood Management Unit Trust will be able to facilitate supply of this disinfection agent through Lovell Surgical Supplies International.
This action has been closed out on the 26/11/2018. |
| Contact Information |
02 9475 4360 - Australian Blood Management Unit Trust |