MEDICAL DEVICE RECALL LISTING JULY & AUGUST 2022

The list below contains Medical Device Recall for the month of July and August 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 JULY & AUGUST 2022

Date of Reporting	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
21 July 2022	MDA/Recall/P0007-33934132-2022	Voluntary Recall	ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE	GB377741336919	Class I	A02: Manufacturing, Packaging or Shipping Problem	COOK ASIA (MALAYSIA) SDN BHD	MDA-1987-WDP121
26 July 2022	MDA/Recall/P0011-43386148-2022	Voluntary Recall	CONNECTORS-MICROCLAVE	GB385541106018	Class III	A02: Manufacturing, Packaging or Shipping Problem	EMERGING SYSTEMS (M) SDN. BHD.	MDA-1614-WDP121
26 July 2022	MDA/Recall/P0012-50437904-2022	Voluntary Recall	SURPLUG	GMD64687955619A	Class III	A02: Manufacturing, Packaging or Shipping Problem	TERUMO MALAYSIA SDN. BHD.	MDA-0794-WDP120
29 July 2022	MDA/PMSV/R2022-034	Voluntary Recall	ARIES HSV 1&2 ASSAY	IVDC44297287118	Class III	A02: Manufacturing, Packaging or Shipping Problem	BMS DIAGNOSTIC (M) SDN. BHD.	MDA-2047-WDP121
01 August 2022	MDA/Recall/P0008-11130643-2022	Voluntary Recall	BREATH-O CORRECT	GB531851277619	Class II	A02: Manufacturing, Packaging or Shipping Problem	SEED CONTACT LENS (M) SDN. BHD.	MDA-0673-WDP67319
01 August 2022	MDA/Recall/P0015-51732636-2022	Voluntary Recall	ENNOVATE SPINAL SYSTEM IMPLANT	GC57325621618	Class III	A21: Labelling, Instructions for Use or Training Problem	B. BRAUN MEDICAL INDUSTRIES SDN BHD	MDA-0078-W7814
01 August 2022	MDA/Recall/P0022-83389237-2022	Voluntary Recall	HOLLOW FIBER DIALYZER	GC97124670918	Class III	A14: Infusion or Flow Problem	B. BRAUN MEDICAL INDUSTRIES SDN BHD	MDA-0078-W7814
03 August 2022	MDA/Recall/P0035-56210981-2022	Voluntary Recall	ADSORBA HEMOPERFUSION CARTRIDGE	GC32251831818	Class I	A02: Manufacturing, Packaging or Shipping Problem	BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.	MDA-1025-WDP120
24 August 2022	MDA/Recall/P0047-67120902-2022	Voluntary Recall	VENTANA MEDICAL SYSTEMS_HISTOLOGY/CYTOLOGY_ HISTOLOGY/CYTOLOGY REAGENTS	IVDA2775457417	Class III	A21: Labelling, Instructions for Use or Training Problem	ROCHE DIAGNOSTICS (M) SDN. BHD. B-20-1 LEVEL 20 THE	MDA-1674-WDP121
25 August 2022	MDA/Recall/P0043-18482428-2022	Voluntary Recall	IMMUCLONE BLOOD GROUPING REAGENTS FOR KELL SYSTEM	IVDD7684924217	Class III	A21: Labelling, Instructions for Use or Training Problem	BMS DIAGNOSTICS (M) SDN BHD	MDA-2047-WDP121
27 August 2022	MDA/Recall/P0049-78561612-2022	Voluntary Recall	HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD)	GD74345985518	Class II	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.