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10020 Pacific Mesa Blvd San Diego, CA 92121 USA BD.current MEDICAL DEVICE RECALL June 9, 2021, Product Name BD MaxPlusTM bi fuse extension set with 2 clear needleless connectorsCatalog (Ref) No. Lot
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Contact the FDA to determine if a recall is necessary.
02
Notify affected distributors, retailers, and customers about the recall.
03
Prepare a recall strategy and a recall communication plan.
04
Prepare recall notification materials such as letters, emails, and press releases.
05
Implement the recall by removing or correcting the affected products.
06
Monitor the effectiveness of the recall and provide updates as necessary.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices who have identified a potential safety issue with their products.
02
Distributors, retailers, and healthcare facilities that have received or sold the affected devices.
03
Government regulatory agencies such as the FDA who oversee the safety and effectiveness of medical devices.
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What is class 2 device recall?
Class 2 device recall is initiated when a device may cause temporary or reversible health problems.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers are required to file class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall must be reported to the FDA through the eSubmitter portal.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to mitigate the risk of harm to the public health.
What information must be reported on class 2 device recall?
Information such as device details, reason for recall, number of affected units, and action plan must be reported on class 2 device recall.
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