Get the free Class 2 Device Recall EXOGEN Ultrasound Coupling Gel
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Invents Operated U.A.
Taurus avenue 31
2132 LS Hoofddorp
The NetherlandsURGENT: MEDICAL DEVICE RECALL
INITIAL NOTIFICATION LETTER
OXYGEN Ultrasound Gel
Potential Contamination +31 (0)23 5548888
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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 of the class 2 device.
02
Notify the appropriate regulatory authorities about the recall.
03
Prepare a recall strategy and communication plan.
04
Contact all affected customers and provide instructions for returning or replacing the devices.
05
Keep detailed records of the recall process and follow up to ensure compliance.
Who needs class 2 device recall?
01
Manufacturers or distributors of class 2 medical devices that have been found to have a defect posing a moderate risk to patients may need to initiate a class 2 device recall.
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What is class 2 device recall?
Class 2 device recall is initiated when a medical device is found to have a moderate risk of causing harm to the patient.
Who is required to file class 2 device recall?
Manufacturers, importers, and distributors are required to file class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall can be filed by submitting a Recall Initiation Form to the appropriate regulatory body.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct devices that pose a moderate risk to patients.
What information must be reported on class 2 device recall?
Class 2 device recall must include information on the affected device, the reason for the recall, and the actions being taken.
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