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.

 MEDICAL DEVICE RECALL LISTING DECEMBER 2022

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

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
 

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