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Perfusion, a wholly owned subsidiary of Benton, Dickinson and Company (BD) 10020 Pacific Mesa Blvd San Diego, CA 92121www.BD.comAttachmentBMedical Device Recall Customer Response Form AlarisPump Module
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How to fill out medical device recall expansion

01
Look for the specific instructions provided by the manufacturer for filling out the medical device recall expansion.
02
Gather all relevant information about the medical device in question, including its serial number, lot number, and date of purchase.
03
Clearly document the reason for the recall expansion, including any potential risks or hazards associated with the device.
04
Provide detailed instructions on how to return or dispose of the recalled device in a safe manner.

Who needs medical device recall expansion?

01
Medical device manufacturers who have identified a need to expand a recall to include additional products or lots.
02
Regulatory authorities overseeing medical device recalls to ensure proper documentation and communication of the expanded recall.
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Medical device recall expansion is the process of extending a previously initiated recall to include additional units or lot numbers of a medical device.
Manufacturers, distributors, or importers of the medical device are required to file a medical device recall expansion.
To fill out a medical device recall expansion, the responsible party must provide specific details about the additional units or lot numbers being included in the expansion.
The purpose of medical device recall expansion is to ensure that all affected units or lot numbers of a defective medical device are accounted for and properly addressed.
The information that must be reported on a medical device recall expansion includes the reason for the expansion, affected product details, and any corrective actions taken.
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