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RECALL: MEDICAL DEVICE RECALL LISTING FEBRUARY 2022
The list below contains Medical Device Recall for the month of February 2022. This 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 FEBRUARY 2022
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
3 February 2022 |
Voluntary recall |
2.5 mm and 3.5 mm Prevail Paclitaxel-coated PTCA Balloon Catheter (Prevail catheter) |
GD9712721-75150 |
Class II |
A21: Labelling, Instruction of use or Training Problems |
Medtronic Malaysia Sdn. Bhd. |
MDA-0074-WDP7414 |
|
|
22 February 2022 |
Voluntary recall |
LiquiBand Fix8 Open Hernia Mesh Fixation device (FX002) |
GC10940220-45817 |
Class III |
A05: Mechanical Problem |
Advanced Medical Solutions Ltd |
MDA-1160-WDP120 |
|
|
28 February 2022 |
Voluntary recall |
2.5 mm and 3.5 mm Prevail Paclitaxel-coated PTCA Balloon Catheter (Prevail catheter) |
GC32354730618 GC946181006118 GC51059813518 |
Class III |
A04: Material Integrity Problem |
Affluent Healthcare Sdn. Bhd. |
MDA-3072-WDP121 |
|
|
8 February 2022 |
Voluntary recall |
1688 Pendulum Camera Head with Integrated Coupler |
GA1026461936035 |
Class III |
A11: Computer software problem |
Stryker Corporation (Malaysia) Sdn. Bhd. |
MDA-542-WDP44515 |
