MEDICAL DEVICE RECALL LISTING AUGUST 2023

The list below contains Medical Device Recall for the month of August 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.

pdf MEDICAL DEVICE RECALL LISTING AUGUST 2023 (136 KB)

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
01/08/2023	MDA/Recall/P0191-38483717-2023	Voluntary Recall	STRYKER MIXEVAC3 BONE CEMENT MIXER	GC12682730018	Class II	A02: Manufacturing, Packaging or Shipping Problem	STRYKER CORPORATION (MALAYSIA) SDN. BHD.	MDA-2123-WDP121
02/08/2023	MDA/Recall/P0195-80159537-2023	Voluntary Recall	VENTANA ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY	IVDC45906209918	Class III	A02: Manufacturing, Packaging or Shipping Problem	ROCHE DIAGNOSTICS (M) SDN. BHD.	MDA-1674-WDP121
04/08/2023	MDA/Recall/P0194-80425453-2023	Voluntary Recall	PDS™ II (POLYDIOXANONE) STERILE SYNTHETIC, ABSORBABLE SUTURE	GD4349722-103519	Class III	A02: Manufacturing, Packaging or Shipping Problem	JOHNSON & JOHNSON SDN BHD	MDA-4880-WDP123
04/08/2023	MDA/Recall/P0196-10265681-2023	Voluntary Recall	PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE	GD10453922-102675	Class III	A02: Manufacturing, Packaging or Shipping Problem	JOHNSON & JOHNSON SDN BHD	MDA-4880-WDP123
28/08/2023	MDA/Recall/P0204-86872369-2023	Voluntary Recall	3M ATTEST SUPER RAPID READOUT BIOLOGICAL INDICATOR 1492V	GMD34608856218A	Class III	A23: Use of Device Problem	3M MALAYSIA SDN BHD	MDA-2255-WP121
29/08/2023	MDA/Recall/P0198-40556954-2023	Voluntary Recall	IMMUNOHAEMATOLOGY BLOOD GROUPING ANTISERA	IVDD52033101418	Class III	A27: Appropriate Term/Code Not Available	UNITED ITALIAN TRADING (M) SDN. BHD	MDA-1847-WDP121
29/08/2023	MDA/Recall/P0205-45964073-2023	Voluntary Recall	BIO-AQUACEL LUBRICANT EYE DROPS	GB9985320-46507	Class II	A18: Contamination / decontamination Problem	FARMASIA SDN BHD	MDA-1705-W121

* 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.