Glossary Term
Recall Management
Definition
Recall management is the process by which a company organizes, coordinates, and executes the removal or correction of a medical device, product, or treatment that has been found to be defective, unsafe, or non-compliant with regulatory standards. It involves identifying the affected products, notifying relevant stakeholders (including customers, healthcare providers, and regulatory bodies), implementing corrective actions, and ensuring that the product is either replaced, repaired, or returned. Effective recall management ensures patient safety, compliance with regulatory requirements, and proper documentation throughout the process.
Relevance to the MedTech Industry
Effective recall management is critical to swiftly and efficiently address product defects or safety issues that could harm patients or violate regulatory standards. By managing recalls effectively, companies ensure that defective products are removed from circulation, patient safety is protected, and the risk of non-compliance with regulatory bodies is minimized. Recall management also helps mitigate reputational damage by demonstrating a company's commitment to quality and patient safety.
Additional Information & Related Terms
Related Terms
Recall Classification: The categorization of recalls based on the risk level, ranging from Class I (high risk) to Class III (low risk).
FDA Medical Device Reporting (MDR): A system used to report adverse events that could trigger a recall in medical device manufacturing.
Corrective and Preventive Action (CAPA): A system for addressing the root causes of non-conformances or defects, often leading to a recall.
Market Withdrawal: A less severe action than a recall, where products are removed from the market but not necessarily because they are harmful.
Recall Effectiveness Check: A process used to verify that a recall was completed successfully and that all affected products were accounted for.