Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Johnson & Johnson Vision Care Inc., QRB-04-2019, 1-DAY ACUVUE® MOIST for ASTIGMATISM

   Wij hebben een beperkt aantal meldingen ontvangen van vreemde deeltjes op de contactlens of in de vloeistof in de blister.

   Waarschuwing | 11-09-2019

2. Smith & Nephew Medical Limited, C-2023-05, Secura No-Sting Skin-Prep.Barrier Film

   Productiefout die resulteert in de aanwezigheid van azijnzuur, wat een azijnachtige geur en mogelijke lichte huidirritatie ...

   Waarschuwing | 17-07-2023

3. Intersurgical FSCA 301083 - CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M

   We have received a complaint where a product that should contain an Adult EcoliteTM Aerosol Mask with vents (Picture 1), has been ...

   Waarschuwing | 17-12-2020

4. TR Equipment AB, FSN-2534, TR Equipment

   It has come to our attention that one of the gears inside the motor gear box of the TR9650 mobile bath lift family, produced ...

   Waarschuwing | 09-06-2020

5. C. R. Bard, UCC-23-4679, agic3 Go.Hydrosil Go Intermittent Silicone Cathet

   Een BD-productielocatie die Magic3 Go / HydroSil Go Intermitterende siliconenkatheters produceert, heeft een niet-conforme ...

   Waarschuwing | 22-05-2023

6. Welch Allvn, Ine., FA-2024-038, Braun Pro 6000

   Baxter Healthcare Corporation has identified that the Braun Thermoscan® PRO 6000 ear thermometers listed below may have been ...

   Waarschuwing | 27-06-2024

7. Draeger Medical Systems Inc., PR129416, Softbed Resuscitaire with Scale

   During the course of our global market surveillance activities, we have become aware of cases in which the Resuscitaire Infant ...

   Waarschuwing | 31-05-2023

8. Insulet Corporation, FSN-9056196-10/11/2022-001-C, Omnipod DASH® Personal Diabetes Manager (PDM)

   We have received reports from some Omnipod DASH users regarding PDM battery issues, including battery swelling, fluid leaking ...

   Waarschuwing | 27-10-2022

9. Tandem Diabetes Care, Inc., FSN-FSCA-2022-02; MDD22.004, t:slim X2 Insulin Pump

   Inputting incorrect values in your Personal Profile can lead to under-delivery or over-delivery of insulin, which could result in ...

   Waarschuwing | 17-02-2022

10. ArjoHuntleigh AB, FSN-FSN-SUZ-001-2021, Nimbus 4 & Nimbus Professional

    Arjo has received limited reports of the Nimbus 4/Professional mattress over-inflating which requires an unusual set of ...

    Waarschuwing | 13-04-2021