Articles by n8n Publisher

Baxter Sigma Spectrum Infusion Pump Software Recall: Critical Lessons for Medical Device Manufacturers

Baxter Sigma Spectrum Infusion Pump Software Recall: Critical Lessons for Medical Device Manufacturers

By n8n Publisher |

Baxter's Sigma Spectrum infusion pump software recall highlights critical compliance lessons for medical device manufacturers…

FDA Announces Bard PowerPICC Catheter Recall: Critical Safety Alert for Medical Device Manufacturers

FDA Announces Bard PowerPICC Catheter Recall: Critical Safety Alert for Medical Device Manufacturers

By n8n Publisher |

FDA recalls Bard PowerPICC intravascular catheters as part of enhanced communication pilot. Critical compliance insights…

H.R. 6594: New Medical Device Recall Improvement Act Could Transform FDA Notification Requirements

H.R. 6594: New Medical Device Recall Improvement Act Could Transform FDA Notification Requirements

By n8n Publisher |

Rep. Schakowsky's H.R. 6594 proposes electronic recall notifications for medical devices. Learn what this means…

Critical Medical Device Recalls of 2025: Compliance Lessons and Litigation Risks for Manufacturers

Critical Medical Device Recalls of 2025: Compliance Lessons and Litigation Risks for Manufacturers

By n8n Publisher |

Major 2024-2025 medical device recalls are driving litigation and regulatory investigations through 2026, revealing critical…

B. Braun Microbore Extension Set Recall: Key Compliance Lessons for Medical Device Manufacturers

B. Braun Microbore Extension Set Recall: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

B. Braun's microbore extension set recall offers critical compliance lessons for medical device manufacturers navigating…

Abiomed Impella Controller Correction: Critical Lessons in Post-Market Instructions Updates

Abiomed Impella Controller Correction: Critical Lessons in Post-Market Instructions Updates

By n8n Publisher |

Abiomed's Impella Controller correction highlights critical compliance lessons for medical device manufacturers in post-market instruction…

Baxter Novum IQ Infusion Pump Correction: Key Compliance Lessons for Medical Device Manufacturers

Baxter Novum IQ Infusion Pump Correction: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

Baxter's Novum IQ infusion pump correction offers key compliance insights for medical device manufacturers navigating…

Medtronic DLP Left Heart Vent Catheter Recall: Critical Lessons for Cardiovascular Device Manufacturers

Medtronic DLP Left Heart Vent Catheter Recall: Critical Lessons for Cardiovascular Device Manufacturers

By n8n Publisher |

Medtronic's DLP Left Heart Vent Catheter recall highlights critical compliance lessons for cardiovascular device manufacturers…

Olympus Polyloop Recall: Critical Lessons for Medical Device Post-Market Surveillance

Olympus Polyloop Recall: Critical Lessons for Medical Device Post-Market Surveillance

By n8n Publisher |

Olympus's voluntary Polyloop corrective action offers critical lessons for medical device manufacturers on post-market surveillance…

GAO Report Exposes Critical FDA Staffing Gaps Affecting Medical Device Recall Oversight

GAO Report Exposes Critical FDA Staffing Gaps Affecting Medical Device Recall Oversight

By n8n Publisher |

GAO audit reveals FDA staffing shortages are delaying medical device recall oversight, forcing manufacturers to…

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