Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Maquet_Getinge FSCA-2020-12-07 - Pediatric Venous Hardshell Cardiotomy Reservoir

   During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was ...

   Waarschuwing | 16-12-2020

2. Maquet Critical Care AB, FSN-MCC 20 009 IU, Heart Lung Machine HL 40 occlusion clamp assembly

   This letter is to inform you that “hot swapping” the electro-mechanical venous occlusion clamp (EVOC) should be avoided while the ...

   Waarschuwing | 09-07-2020

3. Abbott, FSN-FA-Q220-EP-1, TactiCathTM Quartz Contact Force Ablation Catheter

   Dringende veiligheidskennisgeving betreft TactiCathTM Quartz contactkrachtablatiekatheter Model PN-004 065 en PN-004 075.

   Waarschuwing | 28-05-2020

4. Bentley InnoMed GmbH CAPA 20-003 Mesh-sleeve coronary artery stent

   During the last internal quality control (destructive testing during final release test), it was found that there is a potential ...

   Waarschuwing | 22-04-2020

5. US Endoscopy 1528319-02_01_19-R-001 - Padlock Clip defect closure system

   US Endoscopy received a single report of an esophageal laceration during a patient procedure in which our Padlock Clip defect ...

   Waarschuwing | 01-02-2019

6. A&E Medical Corporation 2017-10-20 - SURGICAL PUNCH

   All A&E Medical Surgical Punches are being recalled due to potential packaging damage which may have occurred during ...

   Waarschuwing | 20-10-2017

7. Field Safety Notice: Boston Scientific - Jetstream Atherectomy Catheters

   Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm ...

   Waarschuwing | 06-04-2017

8. Field Safety Notice: Optimed - sinus-SuperFlex-635

   The details of the label on the packaging do not correspond to the delivered product. The information of the inner label on the ...

   Waarschuwing | 31-03-2017

9. Field Safety Notice: Navilyst Medical - Xcela en BioFlo PICC

   Greatbatch Medical heeft vastgesteld dat de handgrepen van de producten in hun terugroepkennisgeving van 11 november 2016 tijdens ...

   Waarschuwing | 30-11-2016

10. Medtronic, FA1203, HawkOne Directional Atherectomy System

    Medtronic heeft meldingen ontvangen van beschadiging van de tip tijdens het gebruik van 6Fr HawkOne-hulpmiddelen, wat in sommige ...

    Waarschuwing | 20-12-2021