Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Zimmer, Inc - ZFA 2019-00062 - Pulsavac Plus Wound Debridement System

   Zimmer Surgical, Inc. is conducting a medical device Field Safety Corrective Action (removal) for lot specific Pulsavac® Plus ...

   Waarschuwing | 08-07-2019

2. Bard Access Systems Inc, FSN-MDS-21-4027, Groshong Catheters

   BD verstuurt een adviserend veiligheidsbericht voor specifieke partijen Groshong-katheterproducten.

   Waarschuwing | 29-04-2021

3. Johnson & Johnson Surgical Vision, 2160299 - FSN2022-03, Veritas Advanced Infusion Packs

   Johnson & Johnson Vision has initiated this Action due to the potential for the irrigation luer to crack or break. A crack or ...

   Waarschuwing | 19-09-2022

4. Terumo BCT Mirasol PRT FA42 - Mirasol Pathogen Reduction Technology System

   Uit recente testen door Terumo Blood and Cell Technologies blijkt dat het endotoxinegehalte de vastgelegde limiet overschreed ...

   Waarschuwing | 17-01-2022

5. Atrium Medical Corporation, 3011175548-02.15,.2023-001-C, Express Mini 500 Dry Seal Chest Drain

   Atrium/Getinge is initiating a voluntary Medical Device Correction for the Atrium Express Mini 500 Dry Seal Chest Drain. The ...

   Waarschuwing | 28-04-2023

6. Baxter FA-2020-016 - Prismaflex Control Unit, PrisMax

   We have received questions from clinicians who are exploring modifying their use of Baxter's PrisMax and Prismaflex Control ...

   Waarschuwing | 27-03-2020

7. Maquet Cardiopulmonary GmbH FSCA-2019-09-11 Adult Small Adult VKMOs and VHK

   During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging barrier was ...

   Waarschuwing | 12-09-2019

8. Maquet Cardiopulmonary GmbH FSCA-2019-09-10 Adult Small Adult Venous Hardshell Cardiotomy Reservoir (VHK) and combination of reservoir with oxygenator (VKMO(D))

   During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging pouches of the ...

   Waarschuwing | 11-09-2019

9. Intuitive Surgical ISIFA2018-09-C - da Vinci Xi EndoWrist Suction Irrigator

   Gebruik de da Vinci Xi EndoWrist-suctie-irrigator NIET bij intracardiale procedures totdat u bericht van Intuitive Surgical hebt ...

   Waarschuwing | 04-01-2019

10. Unimax Medical Systems, Inc., FCA-EP24001, Detachable EndoRetrieval Pouch

    The mechanism of the listed article number operates in a way that the tube within detaches during the removal process. If the ...

    Waarschuwing | 18-03-2024