MEDICAL DEVICE RECALL LISTING NOVEMBER 2022
The list below contains Medical Device Recall for the month of November 2022. 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.
MEDICAL DEVICE RECALL LISTING NOVEMBER 2022
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
11/11/2022 |
Voluntary recall |
TELEFLEX RUSCH URETERAL CATHETERS |
GB46067877818 |
Class II |
A01: Patient Device Interaction Problem |
TELEFLEX MEDICAL SDN.BHD. |
MDA-3058-W121 |
|
|
16/11/2022 (Late reporting) |
MDA/Recall/P0085-15057098-2022 |
Voluntary recall |
ALTERNA® BASEPLATE |
GMD343681007019A |
Class I |
A21: Labelling, Instructions for Use or Training Problem |
DKSH MALAYSIA SDN. BHD. |
MDA-0023-WDP2314 |
|
16/11/2022 (Late reporting) |
MDA/Recall/P0089-77559257-2022 |
Voluntary recall |
ALTERNA® BASEPLATE |
GMD343681007019A |
Class I |
A21: Labelling, Instructions for Use or Training Problem |
DKSH MALAYSIA SDN. BHD. |
MDA-0023-WDP2314 |
|
21/11/2022 |
MDA/Recall/P0090-20968288-2022 |
Voluntary recall |
AQUACEL AG ADHESIVE/NON- ADHESIVE FOAM HYDROFIBER DRESSING |
GD12979451117 |
Class III |
A18: Contamination / decontamination Problem |
CONVATEC MALAYSIA SDN. BHD. |
MDA-1913-W121 |
|
22/11/2022 |
Voluntary recall |
VENTANA PD-L1 (SP142) ASSAY |
IVDC77381365919 |
Class II |
A02: Manufacturing, Packaging or Shipping Problem |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
MDA-1674-WDP121 |
|
|
24/11/2022 |
MDA/Recall/P0093-55791877-2022 |
Voluntary recall |
VLIWAKTIV ABSORBENT ACTIVATED CHARCOAL DRESSING |
GB2547620-42323 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
NYPRAX BUSINESS SOLUTIONS |
MDA-400-WDP30415 |
* 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.
