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MEDICAL DEVICE RECALL LISTING JULY 2024
The list below contains Medical Device Recalls for the month of July 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 JULY 2024 (135 KB)
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
01/07/2024 |
Voluntary Recall |
CAPIO SLIM SUTURE CAPTURING DEVICE |
GB71551564718 |
Class II |
A24: Adverse Event Without Identified Device or Use Problem |
BOSTON SCIENTIFIC (MALAYSIA) SDN BHD |
MDA-5810-WD124 |
|
|
03/07/2024 |
MDA/Recall/P0303-51703664-2024 |
Voluntary Recall |
ALINITY C PROTEINS |
IVDB5170819-34873 |
Class II |
A08: Calibration Problem |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
MDA-5104-W123 |
|
05/07/2024 |
MDA/Recall/P0304-42114480-2024 |
Voluntary Recall |
VASCUGRAFT® NEO |
GC37117108716 |
Class III |
A21: Labelling, Instructions for Use or Training Problem |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
MDA-4250-W123 |
|
09/07/2024
|
Voluntary Recall |
DSD EDGE ENDOSCOPE REPROCESSOR |
GC16706518418 |
Class II |
A21: Labelling, Instructions for Use or Training Problem |
STERIS MALAYSIA SDN. BHD. |
MDA-5302-WDP123 |
|
|
09/07/2024 |
Voluntary Recall |
NIM-NEURO 3.0 SYSTEM AND ACCESSORIES |
GB45802845818 |
Class II |
A23: Use of Device Problem |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
18/07/2024 |
Voluntary Recall |
MCGRATH MAC LARYNGOSCOPE |
GB10147922-107333 |
Class III |
A27: Appropriate Term/Code Not Available |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
23/07/2024 |
Voluntary Recall |
SUSCEPTIBILITY AND IDENTIFICATION TEST FOR MYCOBACTERIA |
IVDC23724200218 |
Class II |
A23: Use of Device Problem |
BECTON DICKINSON SDN BHD |
MDA-5083-W123 |
* The information contained in the Me Voluntary Recall dical Device Authority Recall database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.
