Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus Medical Systems Corporation, FSN-QIL 153-009, OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30S

   Olympus Medical Systems Corporation (“Olympus”) is writing to inform you of a removal action of all OES CHOLEDOCHOFIBERSCOPE ...

   Waarschuwing | 09-09-2020

2. Vascular Solutions LLC, FSN-PL0252 – Rev. B / HRA00079, Langston Dual Lumen Catheter

   Met deze brief informeert Vascular Solutions LLC, onderdeel van Teleflex, u de reikwijdte van hun vrijwillige terugroeping van de ...

   Waarschuwing | 09-09-2020

3. Olympus Medical Systems Corporation, FSN-QIL 153-010, INTESTINAL VIDEOSCOPE OLYMPUS POWERSPIRAL (PSF-1)

   INFORMATION ON ADVERSE EVENTS OBSERVED DURING POWERSPIRAL (PSF-1) PROCEDURES.

   Waarschuwing | 09-09-2020

4. ThermoFisher Scientific-Microbiology Central Reporting, FSN-FSN-2020-0007, ThermoScientificTM OxoidTM F100 Nitrofurantoin

   A technical investigation has confirmed that some packs of Thermo Scientific™ Oxoid™ F100 Nitrofurantoin CT0034B Lot 2961028 may ...

   Waarschuwing | 08-09-2020

5. Gentian AS CC-167 - Gentian Cystatin C Calibrator and Calibrator Kit

   The identified lots of calibrators have shown to measure incorrect high values over time compared to the assigned values when ...

   Waarschuwing | 02-09-2020

6. Micro Therapeutics Inc. DBA ev3 Neurovascular, FSN-FA929, PipelineTM Flex Embolization Device (with Shield TechnologyTM)

   Medtronic is providing this notice regarding a labeling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with ...

   Waarschuwing | 02-09-2020

7. PAUL HARTMANN AG, FSN-10001017624, Tela® products, Longuetten and corresponding procedure trays (CombiSet®)

   The listed Tela® products and Longuetten are gauze products containing an interwoven x-ray detectable thread. The listed ...

   Waarschuwing | 01-09-2020

8. intra special catheters GmbH FSCA200001 - PNEUMOCATH®_NEO-PNEUMOCATH®_THORACATH®-models

   The background to the corrective action is an incident reported by a user concerning the product "Neo­Pneumocath for adults 10F - ...

   Waarschuwing | 01-09-2020

9. Paul Hartmann 10001017624 - Tela® products, Longuetten, and procedure trays (CombiSet®)

   Due to feedback from clinics and the information of the supplier of our x-ray products we learned that the x-ray thread of the ...

   Waarschuwing | 01-09-2020

10. Medeco (Mediq) FSN2020-1 - Klinion Kliniray (Abdominal) Gauze Compress X-Ray

    After an internal assessment of these products, it became known that under tension x-ray contrast threads in gauze compresses ...

    Waarschuwing | 01-09-2020