RECALL: MEDICAL DEVICE RECALL LISTING MARCH 2022

The list below contains Medical Device Recall for the month of March 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 MARCH 2022

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
9 March 2022	MDA/PMSV/R2022- 013	Voluntary recall	Architect STAT Myoglobin Calibrators	IVDC61829231718	Class III	A08: Calibrator problem	Abbott Laboratories (Malaysia) Sdn. Bhd.	MDA-1685-W121
12 March 2022	MDA/PMSV/R2022- 014	Voluntary recall	Alere NT‐proBNP for ARCHITECT & Alinity i	IVDC9794819-26769 IVDC7664219-34593	Class III	A27: Appropriate term/ code not available (Regulatory issue)	Abbott Diagnostics Health Sdn. Bhd.	MDA-1894-WD121
15 March 2022	MDA/PMSV/R2022- 015	Voluntary recall	Triathlon® Primary/Tritanium Tibial Baseplates	GD42222611618 GC48361787918 GD54307362817	Class III	A21: Labelling, instruction for use or training problems	Stryker Corporation (Malaysia) Sdn. Bhd.	MDA-2123-WDP121
17 March 2022	MDA/PMSV/R2022- 016	Voluntary recall	ROTAPROTM Atherectomy System (ROTAWIRE Drive and wireClip Torquer)	GD6612419-26977	Class III	A02: Manufacturing, Packaging or Shipping Problem	Boston Scientific (M) Sdn. Bhd.	MDA-1754-WDP121
18 March 2022	MDA/PMSV/R2022- 017	Voluntary recall	GELITA-SPON® , Absorbable Gelatin Sponge Hemostat	GD97157451717	Class III	A18: Contamination / decontamination Problem	IDS MEDICAL SYSTEMS (M) Sdn. Bhd.	MDA-2377-WDP121
29 March 2022	MDA/PMSV/R2022-018	Voluntary recall	In.Pact Admiral Paclitaxel-Eluting PTA Balloon Catheter	GD42436494017	Class III	A02: Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn. Bhd.	MDA-0074-WDP7414

* 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.\