MEDICAL DEVICE RECALL LISTING MARCH 2023
The list below contains Medical Device Recall for the month of March 2023. These list provides recall reporting information to MDA by establishment in accordance to requirement stipulated in Section 42, Act 737 and Regulation 7 and 8 of 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 Malaysia market. 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 its affected person of its defectiveness or potential defectiveness.
If you have experienced any safety and performance issue 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 MARCH 2023 (128 KB)
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
15/03/2023 |
MDA/Recall/P0128-60818328-2023 |
Voluntary Recall |
ZENITH BRANCH ENDOVASCULAR GRAFT - ILIAC BIFURCATION |
GD6890667816 |
Class II |
A05: Mechanical Problem |
COOK ASIA (MALAYSIA) SDN BHD |
MDA-1987-WDP121 |
|
24/03/2023 |
MDA/Recall/P0130-62798032-2023 |
Voluntary Recall |
InnoQ Ultrasound Gel |
GA10900121-67932 |
Class III |
A04: Material Integrity Problem |
IDS MEDICAL SYSTEMS (M) SDN BHD |
MDA-2377-WDP121 |
|
24/03/2023 |
MDA/Recall/P0133-57936436-2023 |
Voluntary Recall |
PERIPHERAL VASCULAR CATHETHER |
GB8366674516 |
Class III |
A22: Human-Device Interface Problem |
B. BRAUN MEDICAL INDUSTRIES SDN BHD |
MDA-4298-K123 |
|
23/03/2023 |
MDA/Recall/P0134-82763169-2023 |
Voluntary Recall |
SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUB |
GC94666774518 |
Class II |
A02: Manufacturing, Packaging or Shipping Problem |
MEDTRONIC MALAYSIA SDN BHD |
MDA-0074-WDP7414 |
|
30/03/2023 |
MDA/Recall/P0135-75622318-2023 |
Voluntary Recall |
TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723GX |
IVDB2953711516 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
ALL EIGHTS (M) SDN BHD |
MDA-4259-WDP123 |
* 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.
