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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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