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RECALL: MEDICAL DEVICE RECALL LISTING FEBRUARY 2022

The list below contains Medical Device Recall for the month of February 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 FEBRUARY 2022

 

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

3 February 2022

 MDA/PSV/R2022-009

Voluntary recall

2.5 mm and 3.5 mm Prevail Paclitaxel-coated PTCA Balloon Catheter (Prevail catheter)

GD9712721-75150

Class II

A21: Labelling, Instruction of use or Training Problems

Medtronic Malaysia Sdn. Bhd.

MDA-0074-WDP7414

22 February 2022

 MDA/PMSV/R2022- 010

Voluntary recall

LiquiBand Fix8 Open Hernia Mesh Fixation device (FX002)

GC10940220-45817

Class III

A05: Mechanical Problem

Advanced Medical Solutions Ltd

MDA-1160-WDP120

28 February 2022

 MDA/PMSV/R2022- 011

Voluntary recall

2.5 mm and 3.5 mm Prevail Paclitaxel-coated PTCA Balloon Catheter (Prevail catheter)

GC32354730618

GC946181006118

GC51059813518  

Class III

A04: Material Integrity Problem

Affluent Healthcare Sdn. Bhd.

MDA-3072-WDP121

8 February 2022

 MDA/PMSV/R2022- 012

Voluntary recall

1688 Pendulum Camera Head with Integrated Coupler

GA1026461936035

Class III

A11: Computer software problem

Stryker Corporation (Malaysia) Sdn. Bhd.

MDA-542-WDP44515

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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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