MEDICAL DEVICE RECALL LISTING NOVEMBER 2022

The list below contains Medical Device Recall for the month of November 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 NOVEMBER 2022

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
11/11/2022	MDA/Recall/P0080-34550611-2022	Voluntary recall	TELEFLEX RUSCH URETERAL CATHETERS	GB46067877818	Class II	A01: Patient Device Interaction Problem	TELEFLEX MEDICAL SDN.BHD.	MDA-3058-W121
16/11/2022 (Late reporting)	MDA/Recall/P0085-15057098-2022	Voluntary recall	ALTERNA® BASEPLATE	GMD343681007019A	Class I	A21: Labelling, Instructions for Use or Training Problem	DKSH MALAYSIA SDN. BHD.	MDA-0023-WDP2314
16/11/2022 (Late reporting)	MDA/Recall/P0089-77559257-2022	Voluntary recall	ALTERNA® BASEPLATE	GMD343681007019A	Class I	A21: Labelling, Instructions for Use or Training Problem	DKSH MALAYSIA SDN. BHD.	MDA-0023-WDP2314
21/11/2022	MDA/Recall/P0090-20968288-2022	Voluntary recall	AQUACEL AG ADHESIVE/NON- ADHESIVE FOAM HYDROFIBER DRESSING	GD12979451117	Class III	A18: Contamination / decontamination Problem	CONVATEC MALAYSIA SDN. BHD.	MDA-1913-W121
22/11/2022	MDA/Recall/P0092-28460710-2022	Voluntary recall	VENTANA PD-L1 (SP142) ASSAY	IVDC77381365919	Class II	A02: Manufacturing, Packaging or Shipping Problem	ROCHE DIAGNOSTICS (M) SDN. BHD.	MDA-1674-WDP121
24/11/2022	MDA/Recall/P0093-55791877-2022	Voluntary recall	VLIWAKTIV ABSORBENT ACTIVATED CHARCOAL DRESSING	GB2547620-42323	Class III	A02: Manufacturing, Packaging or Shipping Problem	NYPRAX BUSINESS SOLUTIONS	MDA-400-WDP30415

* 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.