MEDICAL DEVICE RECALL LISTING DECEMBER 2022

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

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
7/12/2022	MDA/Recall/P0094-16944702-2022	Voluntary recall	DERMALON MONOFILAMENT NYLON	GD91019252817	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
7/12/2022	MDA/Recall/P0096-97422358-2022	Voluntary recall	MONOSOF MONOFILAMENT NYLON	GD53518252717	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
7/12/2022	MDA/Recall/P0097-18815135-2022	Voluntary recall	SOFSILK WAX COATED SUTURE	GD12174861818	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
7/12/2022	MDA/Recall/P0098-10215629-2022	Voluntary recall	SURGIPRO™ AND SURGIPRO™ II MONOFILAMENT POLYPROPYLENE NONABSORBABLE SUTURES	GD8463221-82094	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
7/12/2022	MDA/Recall/P0099-40978575-2022	Voluntary recall	TICRON™ COATED BRAIDED POLYESTER	GD8531322-90169	Class I	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-0074-WDP7414
9/12/2022	MDA/Recall/P0101-92680590-2022	Voluntary recall	COMPACT INTUITIV PHACOEMULSIFICATION SYSTEM & ACCESSORIES	GC82278603718	Class III	A02: Manufacturing, Packaging or Shipping Problem	JOHNSON & JOHNSON SDN BHD	MDA-0081-WDP415
14/12/2022	MDA/Recall/P0102-54605762-2022	Voluntary recall	NASAL CANNULA	GB720571225118	Class III	A02: Manufacturing, Packaging or Shipping Problem	KL MED SUPPLIES (M) SDN BHD	MDA-2434-WDP121

* 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.

Cetak

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