Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Arrow International, EIF-000346, Arrow® PICC- en JACC-kits

   De dekselband vermeldt de verkeerde verloopdatum voor het product.

   Waarschuwing | 24-04-2019

2. Covidien llc, FSN-FA967, 178083: Surgiwand™ II Auto Suture™ Suction and Irrigation Device 5mm/with L-Hook Tip 5mm/ Spatula 5mm

   The purpose of this letter is to advise you that Medtronic is voluntarily recalling specific production lots of its Covidien ...

   Waarschuwing | 24-03-2021

3. Coloplast A/S, FSN-FSCA_Elefant_20200903, ELEFANT® Suction/irigation device

   Urgent Field Safety Notice ELEFANT® SUCTION/IRRIGATION DEVICE for Specific lots.

   Waarschuwing | 15-09-2020

4. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

   It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

   Waarschuwing | 04-01-2024

5. Beckman Coulter, FA-000135, UniCel DxH Slidemaker Stainer

   In zeldzame gevallen kan de dispense probe worden gebogen als de Sample Aspiration Module(SAM) zich niet in de veilige positie ...

   Waarschuwing | 14-10-2019

6. TRACOE medical GmbH, FSN-TRACOE FSCA 2020-02, TRACOE twist plus, TRACOE experc Set twist plus

   TRACOE medical GmbH have issued a voluntary Field Safety Notice for the TRACOE twist plus, TRACOE experc Set twist plus.

   Waarschuwing | 27-10-2020

7. Update: LifeGlobal Group, 1216677-11.30.2023-001-R, global Medium

   CooperSurgical proactively recalled the aforementioned product lots due to an increase in reports that the embryo development and ...

   Waarschuwing | 28-02-2024

8. Arthrex INC, FSN-R526_NL, Angel cPRP Processing Set (EU)

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 26-04-2021

9. FertiProNV, CAPA 2209-03, FertiCult Mineral Oil

   FertiPro recently received a complaint of FertiCult Mineral Oil - lot FP21FM28 about decreased embryo development rate and ...

   Waarschuwing | 04-10-2022

10. GE Medical Systems FMI 32051 - Giraffe Exam Light en Giraffe Incubator

    GE Healthcare heeft een mogelijk veiligheidsprobleem ontdekt waarbij bepaalde stroomkabels kunnen oververhitten. De betrokken ...

    Waarschuwing | 09-12-2016