Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Tornier INC, RA2023-3322296, Aequalis Flex Revive
Stryker has identified a nonconformance in two specific lots of Aequalis Flex Revive Assembly Screws.
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Integra LifeSciences Mansfield, 2023-HHE-006, Codman Cranial Access Kit without drugs
Tijdens een onderzoek heeft lntegra LifeSciences geconstateerd dat de regelgeving niet werd nageleefd met betrekking tot de ...
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JOYinCARE BV, FSN-20230703, Verbredingsstang
Op basis van een drietal meldingen vanuit de markt is vastgesteld dat er Verbredingsstangen met onvoldoende of geen Loctite in de ...
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Randox Laboratories Ltd., FSN-REC679, LIQUID URINE CONTROL LEVEL 2
Randox Laboratories is conducting a Device Recall for Liquid Urine Controls Level 2, UC5074, lot 1209UC due to the following: ...
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Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0007, Fusion Lithotripsy Extraction Basket
Er zijn afwijkende Fusion-extractievangnetjes voor lithotripsie vervaardigd en gedistribueerd. Deze afwijking in de vervaardiging ...
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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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Olympus Medical Systems Corporation, QIL FY24-EMEA-06-FY24-OMSC-04c, BF-Series Endoscopes
Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma ...
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ELITech Clinical Systems SAS, FSN-2306VIG01, LACTATE
In extreme Lactic Acidosis, Lactate levels may rise to >5 mmol/L (45 mg/dL), hence the revised range, in combination with the ...
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Mölnlycke Health Care AB, FSN-2023-06(03), Emergency Chest Re-opening Pack, ANZ Emergency Chest Re-opening Pack, NZ Emergency Chest Re-opening Pack, Acute thorax tray, Thorax trauma tray
Mölnlycke has recently been informed by the Legal Manufacturer Blink Medical, that they are performing a recall on products ...
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FUJIFILM Irvine Scientific Inc, FSN-FSCA2023-002, Oil for Embryo Culture
Per the delivery note on your order, your facility should have received lot 0000011349; however, your facility received lot ...