RECALL: MEDICAL DEVICE RECALL LISTING MAY 2022

The list below contains Medical Device Recall for the month of May 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 MAY 2022

 

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
5 May 2022	MDA/PMSV/R2022- 026	Voluntary Recall	1. Nester® Embolization Microcoil 2. Tornado® Embolization Microcoil	GD68462176917 GD34698117417	Class II	A02: Manufacturing, Packaging or Shipping Problem	COOK ASIA (MALAYSIA) SDN BHD	MDA-1987-WDP121
17 May 2022	MDA/PMSV/R2022- 027	Voluntary Recall	EEA AUTO SUTURE CIRCULAR STAPLER	GC83267552518	Class III	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD.	MDA-0074-WDP7414

* 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.