Get the free Class 2 Device Recall Hookup Accessories - accessdata.fda.gov
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URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION
Hookup Accessories used with MEDIATORS ADVANTAGE PLUS,
ADVANTAGE PLUS Pass Through, and ISA Automated Endoscope Re processors
November 20, 2023,
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Identify the reason for the recall
02
Notify relevant regulatory authorities
03
Notify affected customers
04
Provide detailed instructions on how to return or dispose of the recalled devices
05
Document all actions taken during the recall process
Who needs class 2 device recall?
01
Companies that have distributed class 2 medical devices
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What is class 2 device recall?
A Class 2 device recall involves products that may cause temporary or medically reversible adverse effects or where the probability of serious adverse effects is remote.
Who is required to file class 2 device recall?
The manufacturer, distributor, or importer of the medical device is required to file a Class 2 device recall.
How to fill out class 2 device recall?
To fill out a Class 2 device recall, the entity must submit a report to the FDA that includes details about the device, the reason for the recall, and the corrective actions being taken.
What is the purpose of class 2 device recall?
The purpose of a Class 2 device recall is to protect public health by removing or correcting products that may pose a risk of temporary harm or may lead to serious adverse health consequences.
What information must be reported on class 2 device recall?
The report must include the device name, model number, lot number, reason for recall, corrective actions, and any necessary instructions for healthcare providers and patients.
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