Get the free Class 2 Device Recall BD Precision Glide Needle

BD Medical 1 Benton Drive Franklin Lakes, NJ 07417 USA BD.nonmedical DEVICE RECALL BD PrecisionGlideTM Needle January 13, 2020, Product DescriptionCatalog No. Lot No. Expiration Dated PrecisionGlideTM305187903081230382903051879March

How to fill out class 2 device recall

How to fill out class 2 device recall

1. Verify if the device falls under class 2 recall criteria.
2. Collect all necessary information about the device and the recall reason.
3. Notify the appropriate regulatory authorities about the recall.
4. Prepare a recall strategy and plan for how to handle the recall process.
5. Notify all affected customers and provide instructions on how to return or replace the device.

Who needs class 2 device recall?

1. Manufacturers or distributors of medical devices that have been classified as class 2 devices and have been found to have a defect or pose a risk to patient safety.

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What is class 2 device recall?

Class 2 device recall is a classification assigned to a medical device recall when the use of, or exposure to, the device may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Who is required to file class 2 device recall?

Manufacturers, distributors, and importers of medical devices are required to file a class 2 device recall with the appropriate regulatory agency.

How to fill out class 2 device recall?

To fill out a class 2 device recall, the responsible party must gather all necessary information regarding the device, the reason for the recall, potential risks, and any actions that need to be taken.

What is the purpose of class 2 device recall?

The purpose of a class 2 device recall is to inform the public and regulatory agencies about potential risks associated with a medical device and to initiate corrective actions to prevent harm to patients.

What information must be reported on class 2 device recall?

Information such as the name and model of the device, the reason for the recall, potential health risks, the number of units affected, and the corrective actions to be taken must be reported on a class 2 device recall.