| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01389-1 |
| Product Name/Description |
PLS Set, PLS Set Plus and HIT Set PLS Plus
ARTG 192105
(Getinge Australia Pty Ltd - Tubing Set with BIOLINE Coating (Permanant Life Support) - Tubing set, heart-lung bypass) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
During internal investigation Maquet Cardiopulmonary GmbH (MCP) has identified that the packaging material (medical paper) of the PLS Set components recirculation line and scissors is inadequate to maintain the sterile barrier after removal from the primary sterile packaging (open Tyvek on the tray) if not consumed immediately during the priming process.
The affected packaging material of accessories might get damaged during the transportation and the damages might remain undetected as they are too small to identify them with naked eye.
There have been no reports of complaints of serious injuries or deaths are known associated to the issue to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are informed by Getinge that new packaging material will be implemented by December 2022.Meanwhile customers are informed that PLS Set must be consumed immediately after opening the Tyvek lid of the PLS Set tray, including the supplied scissors to cut the main line. All remaining components that are not consumed during the priming process, must be disposed.Customers are also advised that for the use of the recirculation line to wean the patient from the extracorporeal circulation, they must take a recirculation line from a new PLS set. The remaining components of the PLS set must be disposed after extraction of the recirculation line.Customers are advised to report any adverse events in regard to the affected products to Getinge. |
| Contact Information |
1800 438 464 - Customer Service - Getinge |