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.