| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01090-1 |
| Product Name/Description |
XVIVO Disposable Lung Circuit
Model Number: HQV89200
ARTG 281987
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Lung donor-organ preservation/evaluation system chamber set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Maquet Cardiopulmonary, the manufacturer of the XVIVO Disposable Lung Circuit included in XVIVO Perfusion’s XPS Disposable Lung Kit, has identified the potential for a breach to occur in the sterile packaging barrier. Maquet has received customer complaints for other CTPs involving perforation of the Tyvek during transit.
Maquet Cardiopulmonary GmbH determined the following hazardous situations for the potential breaching of the sterile barrier:
· Patient, user or other persons are exposed to pathogenic agents
· Patient is exposed to pathogenic agents
· Patient is exposed to inappropriately low blood flow
· Product exchange/replacement |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
If the products are necessary based on expert clinical judgement, users can use the devices after following these inspection measures:
· Prior to use, the XVIVO Disposable Lung circuit covers must be checked visually for any damages, holes or tears.
· After removing the tray from the secondary package (white cardboard box), position the tray in a well-lit area outside the sterile field.
· Check the integrity of the sterile barrier of the tray and Tyvek cover before use using the provided Inspection Instruction from Maquet (Annex IV).
· If any doubt arises as to package integrity, then it should not be used. Any product with damaged packaging must be returned to XVIVO Perfusion. To arrange for product return, please contact customersupport@xvivogroup.com.
This action has been closed out on 22/03/2024 |
| Contact Information |
02 9006 1662 - Emergo Australia |