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The document is a Medical Device Recall Reporting Form intended for manufacturers and importers to report recalls to Health Canada as required by regulations. It includes sections for device identification, manufacturer details, reasons for recall, risk evaluation, distribution information, and proposed recall strategies. The specific case involves the HydraSense® Advanced Formula Eye Drops due to incorrect labeling, with no expected medical risk identified.

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Click ‘Get Form’ to open it in the editor.
Begin by selecting your submitter type: Manufacturer or Importer. If you are an importer, indicate if you are reporting on behalf of the manufacturer.
Fill in the device name and identifier in section 64(a). Include any additional device-related information such as license numbers.
In section 64(b), provide the name and address of both the manufacturer and importer. Ensure accuracy for effective communication.
For section 64(c), succinctly describe the reason for the recall, limiting your response to 50 words. Attach any necessary documents for further clarification.
Complete sections 64(d) through 64(k) by evaluating risks, detailing affected units, and providing contact information for follow-up inquiries.

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What is a Class 1 recall on a medical device?

Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Who can initiate a medical device recall?

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things: Initiates a recall (through correction or removal) Notifies the FDA.

What is the CFR for medical device recall?

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority.

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What is a Class 1 medical device recall?

A Class 1 medical device recall addresses medical devices that reasonably could result in serious injuries or death to consumers.

What is the recall process for medical devices?

Recall procedures require companies to evaluate the risk associated with a device when they are developing their recall strategy. The extent and type of the recall action depend on the hazards and harm associated with using the defective device.

Get the free Medical Device Recall Reporting Form - Final - DocHub 2026

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Get the free Medical Device Recall Reporting Form - Final - DocHub 2026

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How to use or fill out Get the free Medical Device Recall Reporting Form - Final - DocHub

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Got questions?

Can I sign my Get the free Medical Device Recall Reporting Form - Final - DocHub with my phone?

How do you fill out Get the free Medical Device Recall Reporting Form - Final - DocHub online?

What is a Class 1 recall on a medical device?

Who can initiate a medical device recall?

What is the CFR for medical device recall?

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