| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-01509-1 |
| Product Name/Description |
Quadrox-I Pediatric Oxygenator HMO 31000 with Pediatric Venous Hardshell Cardiotomy Reservoir VHK 31000
Material: 701049185
Lot range: 92268312 - 92305358
ARTG 144688
(Getinge Australia Pty Ltd - Oxygenator, extracorporeal membrane) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/12/2020 |
| Responsible Entity |
|
| Reason/Issue |
During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was identified.
The size of the breaches in the sterile barrier are small and potentially not detectable with the naked eye. Exposure to a non-sterile or potentially non-sterile medical device may result in infection causing inflammatory-like syndromes thereby deteriorating the clinical state of the patient. Additionally, infection may occur if the device is connected to the central circulatory system.
To date, Maquet Cardiopulmonary / Getinge has not received any complaints or reports of adverse events due to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately return all affected products in their stock to their local Getinge representative. Customers should match lot numbers on labels in their stock with the affected lots according to the Annex I List (supplied to impacted facilities by the sponsor) of affected products. Customers should contact their local Getinge representative for credit.
This action has been closed out on 12/08/2021 |
| Contact Information |
1800 438 464 - Getinge Australia Customer Service |