MEDICAL DEVICE RECALL LISTING JUNE 2023

The list below contains Medical Device Recall for the month of June 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 JUNE 2023

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
01/06/2023	MDA/Recall/P0171-13423663-2023	Voluntary Recall	VERITAS VISION SYSTEM	GC2538221-71446	Class III	A26: Insufficient Information	JOHNSON & JOHNSON SDN BHD	MDA-4880-WDP123
02/06/2023	MDA/Recall/P0170-25517312-2023	Voluntary Recall	PATIENT CONNECTIONS	GB491791268519	Class II	A02: Manufacturing, Packaging or Shipping Problem	KL MED SUPPLIES (M) SDN BHD	MDA-2434-WDP121
14/06/2023	MDA/Recall/P0176-61388126-2023	Voluntary Recall	ROTATING SPINE POSITIONERS	GA9655122-88079	Class II	A23: Use of Device Problem	WELCH ALLYN MALAYSIA SDN BHD	MDA-310-W21615
29/06/2023	MDA/Recall/P0182-83668044-2023	Voluntary Recall	MAHURKAR ACUTE DUAL AND TRIPLE LUMEN CATHETER KIT	GD10956523-131786	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-4793-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