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.

MEDICAL DEVICE RECALL LISTING MARCH 2023

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.