• Home
  • Recall
  • MEDICAL DEVICE RECALL LISTING NOVEMBER 2022

MEDICAL DEVICE RECALL LISTING NOVEMBER 2022

The list below contains Medical Device Recall for the month of November 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 NOVEMBER 2022

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

11/11/2022

MDA/Recall/P0080-34550611-2022

Voluntary recall

TELEFLEX RUSCH URETERAL CATHETERS

GB46067877818

Class II

A01: Patient Device Interaction Problem

TELEFLEX MEDICAL SDN.BHD.

MDA-3058-W121

16/11/2022

(Late reporting)

MDA/Recall/P0085-15057098-2022

Voluntary recall

ALTERNA® BASEPLATE

GMD343681007019A

Class I

A21: Labelling, Instructions for Use or Training Problem

DKSH MALAYSIA SDN. BHD.

MDA-0023-WDP2314

16/11/2022 (Late reporting)

MDA/Recall/P0089-77559257-2022

Voluntary recall

ALTERNA® BASEPLATE

GMD343681007019A

Class I

A21: Labelling, Instructions for Use or Training Problem

DKSH MALAYSIA SDN. BHD.

MDA-0023-WDP2314

21/11/2022

MDA/Recall/P0090-20968288-2022

Voluntary recall

AQUACEL AG ADHESIVE/NON- ADHESIVE FOAM HYDROFIBER DRESSING

GD12979451117

Class III

A18: Contamination / decontamination Problem

CONVATEC MALAYSIA SDN. BHD.

MDA-1913-W121

22/11/2022

MDA/Recall/P0092-28460710-2022

Voluntary recall

VENTANA PD-L1 (SP142) ASSAY

IVDC77381365919

Class II

A02: Manufacturing, Packaging or Shipping Problem

ROCHE DIAGNOSTICS (M) SDN. BHD.

MDA-1674-WDP121

24/11/2022

MDA/Recall/P0093-55791877-2022

Voluntary recall

VLIWAKTIV ABSORBENT ACTIVATED CHARCOAL DRESSING

GB2547620-42323

Class III

A02: Manufacturing, Packaging or Shipping Problem

NYPRAX BUSINESS SOLUTIONS

MDA-400-WDP30415

* 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.

 

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
 

Today 990 Yesterday 5332 Week 29207 Month 48893 Visitor Counter: 117348740

  • Last Modified: 09 June 2023.
facebooktwitterinstagramyoutube
Copyright © 2023 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768