MEDICAL DEVICE RECALL LISTING SEPTEMBER 2022

The list below contains Medical Device Recall for the month of September 2022. 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 SEPTEMBER 2022

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
1 September 2022	MDA/Recall/P0050-96747583-2022	Voluntary recall	TELEFLEX GIBECK ISO-GARD FILTER WITH CATHETER MOUNT	GB19922768318	Class II	A23: Use of Device Problem	TELEFLEX MEDICAL SDN.BHD	MDA-3059-K121
1 September 2022	MDA/Recall/P0053-35044341-2022	Voluntary recall	PREVAIL PACLITAXEL-COATED PTCA BALLOON CATHETER	GD9712721-75150	Class II	A21: Labelling, Instructions for Use or Training Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
5 September 2022	MDA/Recall/P0054-89062176-2022	Voluntary recall	VERITAS VISION SYSTEM	GC2538221-71446	Class III	A24: Adverse Event Without Identified Device or Use Problem	JOHNSON & JOHNSON SDN BHD.	MDA-0081-WDP415
5 September 2022	MDA/Recall/P0055-75032065-2022	Voluntary recall	HD-BLOODLINES AV-SETS	GB110721062918	Class III	A02: Manufacturing, Packaging or Shipping Problem	FRESENIUS MEDICAL CARE MALAYSIA SDN BHD	MDA-1215-WDP120

* 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.