| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00203-1 |
| Product Name/Description |
MICROPLAS plasmafilter
Product Code: MPS05
Lots: 1506260018, 1702000030, 1709000022 & 1710000418
Product Code: MPS07
Lots: 1504300103, 1609000340, 1707000258, 1712000179, 1803000104 & 1805000371
ARTG 178235
(Medline International Two Australia Pty Ltd - Filter, apheresis) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/03/2020 |
| Responsible Entity |
|
| Reason/Issue |
Medline has been informed by Medtronic regarding a potential risk associated with specific production lots of MICROPLAS plasmafilters. In March 2018, Medtronic (Bellco) initiated a Safety Notice following two customer reports where a Bellco MICROPLAS plasmafilter was inadvertently used instead of a hemofilter during continuous renal replacement therapy. In one of these incidents, the use of an incorrect device resulted in patient death.
In November 2018, an additional label was added to the device to further warn the user that the MICROPLAS plasmafilter is intended “For Plasma Separation Only.” After implementation of the additional warning label, another incident occurred where a MICROPLAS plasmafilter was inadvertently used instead of a hemofilter. This occurred with a MICROPLAS plasmafilter that was shipped prior to implementation of the additional warning label.
This recall affects only products that do not have the additional warning label. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medline is advising customers to immediately quarantine and discontinue use of affected lots. Following receipt of a completed Reply Form (provided to impacted customers), Medline will contact facilities and arrange return of any affected product.
This action has been closed out on 17/11/2020 |
| Contact Information |
1800 110 511 - Medline Customer Service Team |