fas fa-search
MEDICAL DEVICE RECALL LISTING JUNE 2024
The list below contains Medical Device Recalls for the month of June 2024. This list provides recall reporting information to the Malaysian Medical Device Authority (MDA) by establishments in accordance with the requirements stipulated in Section 42, Act 737, and Regulations 7 and 8 of the Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysian market. A recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied, and to notify affected persons of its defectiveness or potential defectiveness.
If you have experienced any safety or performance issues with one of the medical devices listed for recall action, please seek advice from your healthcare professional as soon as possible.
pdf MEDICAL DEVICE RECALL LISTING JUNE 2024 (129 KB)
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
07/06/2024 |
Voluntary Recall |
DR WOUND NANO SILVER SPRAY |
GC3497719-26935 |
Class II |
A18: Contamination / decontamination Problem |
FARMASIA SDN BHD |
MDA-5666-K124 |
|
|
21/06/2024 |
Voluntary Recall |
LINQ II™ INSERTABLE CARDIAC MONITOR |
GD1544422-94694 |
Class I |
A02: Manufacturing, Packaging or Shipping Problem |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
18/06/2024 |
Voluntary Recall |
Cobas HBV |
IVDD5502023-131998 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
MDA-5585-WDP124 |
|
|
24/06/2024
|
Voluntary Recall |
AUTOSTAINER LINK 48 |
IVDA321495216 |
Class III |
A07: Electrical /Electronic Property Problem |
BITA LIFESCIENCE SDN. BHD. |
MDA-4664-WDP123 |
|
|
27/06/2024 |
Mandatory Recall |
TRANSMISSION GEL |
GA13780404317 |
Class II |
A18: Contamination / decontamination Problem |
MYMEDIC INNOVATION SDN BHD |
MDA-5449-K124 |
* The information contained in the Medical Device Authority Recall database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.
