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RECALL: MEDICAL DEVICE RECALL LISTING JUNE 2022

The list below contains Medical Device Recall for the month of June 2022. This 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 JUNE 2022

 

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

31 May 2022

pdf MDA/PMSV/R2022-028 (1.40 MB)

Voluntary Recall

Nucleus 7 Processing Unit (CP1000) - Black, Platinum Detail

GC858411305719

Class III

A07: Electrical /Electronic Property Problem

Cochlear Malaysia Sdn Bhd                     

MDA-824-W70415

1 June 2022

 MDA/PMSV/R2022-029

Voluntary Recall

Parallel plate applicators for CoolSculpting

GB59450175217

Class III

A24: Adverse Event Without Identified Device or Use Problem

Allergan Malaysia Sdn Bhd

MDA-1461-W120

6 June 2022

 MDA/PMSV/R2022-030

Voluntary Recall

- Triathlon Solid Cr Tibial Insert Trial Size 2 - 9mm (5530-T-209y) Lot:  A234p

- Triathlon Solid Cr Tibial Insert Trial Size 2 - 10mm (5530-T-210y) Lot: A234q

GD42222611618

 

A21: Labelling, Instructions for Use or Training Problem

Stryker Corporation (Malaysia) Sdn Bhd         

MDA-2123-WDP121

14 June 2022

 MDA/PMSV/R2022-031

Voluntary Recall

1. Mahurkar Chronic Carbothane Catheter Kit

2. Palindrome Chronic Catheter Kit

3. Palindrome H Chronic Catheter Kit

4. Palindrome HSI Chronic Catheter Kit

5. Palindrome SI Chronic Catheter 

1. GD64605629118

2. GD31135554618

3. GD92330689518

4. GD54204598918

5. GD99473820318

Class II

A02: Manufacturing, Packaging or Shipping Problem

Medtronic Malaysia Sdn Bhd                            

MDA-0074-WDP7414

20 June 2022

MDA/PMSV/R2022-032

Voluntary Recall

DOG1 (SP31) Rabbit Monoclonal Antibody

IVDB87950214718

Class II

-

Roche Diagnostics (M) Sdn Bhd                     

MDA-1674-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.

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  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 
  mdb [AT] mda [DOT] gov [DOT] my

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  • Last Modified: 27 January 2023.
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