Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
466 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Cook Vandergrift Inc., 2023FA0008, Lead Clippers
Cook Medical Vandergrift heeft vastgesteld dat de V-vormige verzegeling van de draadknipperverpakking volledig verbroken kan ...
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Gyrus ACMI Inc., QIL FY24-EMEA-05-FY23-OSTA-17, UroPass Ureteral Access Sheath Set
The investigation showed that reported breakages were associated with devices aged more than three years.
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MEDICREA INTERNATIONAL S.A., FSN-FA1335, GRANVIA-C, IMPIX ALIF, IMPIX ALIF S/A, IMPIX C+. IMPIX DLIF, IMPIX MANTA, IMPIX MANTA+, IMPIX S, IMPIX TLIF, PASS LP
Tijdens een intern onderzoek ontdekte Medtronic de mogelijkheid van een productconformiteitsprobleem in de vorm van een gaatje in ...
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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 ...
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TROKAMED GmbH, 2023 VIG 105233 Morcellator, Griffmodul V2.0 5-times-use Morcellator System
In rare cases, the Cutting Module may continue to rotate even though the activation switch on the Grip Module has been released.
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NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve
NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...
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FSN-FSCA 272, Aesculap AG, Laparoscopic access
We detected a non-conformity to the product specification of part number FF399R caused by a manufacturing deviation. The affected ...
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VYGON, FSN-23 0203, Kocher forceps in delivery sets
When Kocher forceps are used for clamping the umbilical cord, a permanent monitoring must be ensured to prevent them from ...
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SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®
Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...
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Medtronic Inc., FSN-FA1342, Durepair Dura Regeneration Matrix
Medtronic was informed by the contract manufacturer (Integra LifeSciences Boston) that based on internal investigation they have ...