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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.\

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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@mda.gov.my

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  • Last Modified: 11 August 2022.
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