RECALL: MEDICAL DEVICE RECALL LISTING APRIL 2022

The list below contains Medical Device Recall for the month of April 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 APRIL 2022

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason Of Recall	Recalling Establishment	Establishment License
1 April 2022	MDA/PMSV/R2022-019	Voluntary Recall	Exeter V40 Cemented Hip Stem	GC23592916318 GC8157019-32104	Class III	A21: Labelling, Instructions for Use or Training Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
5 April 2022	MDA/PMSV/R2022-020	Voluntary Recall	Disposable Grasping Forceps [Model No: FG-51D]	GB267901024018	Class II	A05: Mechanical Problem	Olympus (Malaysia) Sdn Bhd	MDA-2218-WDP121
1 April 2022	MDA/PMSV/R2022-021	Voluntary Recall	Triathlon® Tritanium® Tibial Component (Size 6) – 5536-B-600 Triathlon® Tritanium® Tibial Component (Size 5) – 5536-B-500	GD42222611618	Class II	A21: Labelling, Instructions for Use or Training Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-2123-WDP121
7 April 2022	MDA/PMSV/R2022-022	Voluntary Recall	Cobas cuvette	IVDA9186284817	Class III	A02: Manufacturing, Packaging or Shipping Problem	Roche Diagnostics (M) Sdn Bhd	MDA-1674-WDP121
1 April 2022	MDA/PMSV/R2022-023	Voluntary Recall	Reagent: Albumin in Urine/CSF (Microalbumin)	IVDB8526619-35899	Class II	A04: Material Integrity Problem	Sysmex Malaysia Sdn Bhd	MDA-515-WDP41815
13 April 2022	MDA/PMSV/R2022-024	Voluntary Recall	Arm and Tray Cover Sterile	GC82278603718	Class IIII	A02: Manufacturing, Packaging or Shipping Problem	Johnson & Johnson Sdn Bhd	MDA-0081-WDP415
14 April 2022	MDA/PMSV/R2022-025	Voluntary Recall	17731; 17732 - Gibeck® Humid‐Vent® 2S Flex DC 19061; 19062 - Gibeck® Humid‐Vent® Filter Compact S with Smooth‐Flo® / Swivel 19812 - Gibeck® Humid‐Vent® Filter Compact S with Flex Tube 20011 - Flex Tube 22511; 22512 - Smooth‐Flo® Flex with Double Swivel 22552 - Smooth‐Flo® Flex	GB439621028018 GB57567332017 GB628421055618	Class II	A12: Connection Problem A14: Infusion or flow problem	Teleflex Malaysia Sdn Bhd	MDA-3059-K121

* 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.