The list below contains Medical Device Recall for the month of January 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 JANUARY 2023

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

13 January 2023

MDA/Recall/P0106-84504416-2023

Voluntary recall

COVERA PLUS COVERED VASCULAR STENT

GD8549319-32164

Class III

A05: Mechanical Problem

BECTON DICKINSON SDN. BHD.

MDA-0033-W3314

25 January 2023

MDA/Recall/P0111-68100620-2023

Voluntary recall

IRVINE SCIENTIFIC MEDIA FOR ASSISTED REPRODUCTIVE

GD56583937918

Class III

A04: Material Integrity Problem

LABIVF (M) SDN. BHD.

MDA-3218-WDP122

30 January 2023

MDA/Recall/P0113-95103752-2023

Voluntary recall

EXTENSION FLUID LINES FOR PRESSURE AND GRAVITY INFUSIONS

GB92776178817

Class II

A22: Human-Device Interface Problem

B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

MDA-4250-W123

* 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.