MEDICAL DEVICE RECALL LISTING MAY 2023

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

MEDICAL DEVICE RECALL LISTING MAY 2023

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
03/05/2023	MDA/Recall/P0152-94493240-2023	Voluntary Recall	TELEFLEX WECK METAL LIGATING CLIPS (HORIZON)	GD84037633018	Class II	A02: Manufacturing, Packaging or Shipping Problem	TELEFLEX MEDICAL SDN.BHD.	MDA-3059-K121
05/05/2023	MDA/Recall/P0154-79475888-2023	Voluntary Recall	QUICKCLIP-SINGLE USE ROTATABLE CLIP FIXING	GB58901283217	Class II	A02: Manufacturing, Packaging or Shipping Problem	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121
17/05/2023	MDA/Recall/P0158-74970035-2023	Voluntary Recall	CELL-DYN EMERALD 22	IVDB5774422-110093	Class II	A10: Temperature Problem	ABBOTT LABORATORIES (MALAYSIA) SDN. BHD.	MDA-1685-W121
19/05/2023	MDA/Recall/P0160-78943884-2023	Voluntary Recall	UROPASS URETERAL ACCESS SHEATH SET	GB32940617118	Class II	A04: Material Integrity Problem	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121
24/05/2023	MDA/Recall/P0159-92691485-2023	Voluntary Recall	GELITA-SPON	GD97157451717	Class III	A25: No Apparent Adverse Event	IDS MEDICAL SYSTEMS (M) SDN. BHD.	MDA-2377-WDP121
24/05/2023	MDA/Recall/P0161-74043748-2023	Voluntary Recall	TELEFLEX MEDICAL RUSCH BRONCHOPART DOUBLE LUMEN BRONCHIAL TUBE	GB16263304517	Class II	A18: Contamination / decontamination Problem	TELEFLEX MEDICAL SDN.BHD.	MDA-3059-K121
24/05/2023	MDA/Recall/P0164-62777011-2023	Voluntary Recall	TELEFLEX RUSCH TRACHEAL TUBES (UNCUFFED)	GB449871169418	Class II	A18: Contamination / decontamination Problem	TELEFLEX MEDICAL SDN.BHD.	MDA-3059-K121
24/05/2023	MDA/Recall/P0166-67878571-2023	Voluntary Recall	ENDOTRACHEAL TUBE	GB87665877718	Class II	A18: Contamination / decontamination Problem	TELEFLEX MEDICAL SDN.BHD.	MDA-3059-K121

* 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.