MEDICAL DEVICE RECALL LISTING NOVEMBER 2023

The list below contains Medical Device Recall for the month of November 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 NOVEMBER 2023 (128 KB)

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
02/11/2023	MDA/Recall/P0212- 72826560-2023	Voluntary Recall	EVOLUTION 3E SYSTEM AND ACCESSORIES	GB661621228518	Class III	A02: Manufacturing, Packaging or Shipping Problem	MANDARIN OPTO- MEDIC SDN BHD	MDA-4750- WDP123
09/11/2023	MDA/Recall/P0141- 50000072-2023	Voluntary Recall	INJETAK ADJUSTABLE TIP NEEDLES	GB142131040418	Class III	A23: Use of Device Problem	MKS MEDIC SDN BHD	MDA-1358- WDP120
10/11/2023	MDA/Recall/PX0220- 74798217-2023	Voluntary Recall	DRUG ELUTING PTCA BALLOON CATHETER	GD78955336517	Class III	A21: Labelling, Instructions for Use or Training Problem	B. BRAUN MEDICAL INDUSTRIES SDN BHD	MDA-4250- W123
21/11/2023	MDA/Recall/P0224- 40067213-2023	Voluntary Recall	LIAISON® CHLAMYDIA TRACHOMATIS	IVDC4404721- 55981	Class III	A08: Calibration Problem	DIAGNOSTICARE SDN BHD	MDA-4336- WDP123
29/11/2023	MDA/Recall/P0225- 45953445-2023	Voluntary Recall	DIASYS SUBSTRATE KIDYNEY PROFILE	IVDB5581820- 40159	Class III	A08: Calibration Problem	SYSMEX (MALAYSIA) SDN BHD	MDA-4997- 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.