Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Medline Industries
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Stryker Communications
Class I - Dangerous
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Boston Scientific
Class I - Dangerous
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Their is the potential for weak staining which may result in false negative CD20 identification.
Class I - Dangerous
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class I - Dangerous
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Their is the potential for weak staining which may result in false negative CD20 identification.
Their is the potential for weak staining which may result in false negative CD20 identification.