MEDICAL DEVICE RECALL LISTING SEPTEMBER 2022

The list below contains Medical Device Recall for the month of September 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 SEPTEMBER 2022

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

1 September 2022

MDA/Recall/P0050-96747583-2022

Voluntary recall

TELEFLEX GIBECK ISO-GARD FILTER WITH CATHETER MOUNT

GB19922768318

Class II

A23: Use of Device Problem

TELEFLEX MEDICAL SDN.BHD

MDA-3059-K121

1 September 2022

MDA/Recall/P0053-35044341-2022

Voluntary recall

PREVAIL PACLITAXEL-COATED PTCA BALLOON CATHETER

GD9712721-75150

Class II

A21: Labelling, Instructions for Use or Training Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-0074-WDP7414

5 September 2022

MDA/Recall/P0054-89062176-2022

Voluntary recall

VERITAS VISION SYSTEM

GC2538221-71446

Class III

A24: Adverse Event Without Identified Device or Use Problem

JOHNSON & JOHNSON SDN BHD.

MDA-0081-WDP415

5 September 2022

MDA/Recall/P0055-75032065-2022

Voluntary recall

HD-BLOODLINES AV-SETS

GB110721062918

Class III

A02: Manufacturing, Packaging or Shipping Problem

FRESENIUS MEDICAL CARE MALAYSIA SDN BHD

MDA-1215-WDP120

* 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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