Class 1 Recalls Go to the FDA website and find the medical device recalls page.

Class 1 Recalls
Go to the FDA website and find the medical device recalls page. From either the 2019 or 2020 medical device recalls page, choose a product from the listing that has a Class I recall. FDA Medical Recall Database:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfmLinks to an external site.
1. Define recall. Define Class I recall.
2. Provide the name of the manufacturer (company), distributor or importer that initiated the recall. Or identify if the FDA mandated that the manufacturer initiate the recall.
3. Outline the problem in two-five sentences that lead to the recall. Was it a device malfunction? Was it a wrong result?
4. Why was the recall classified as Class I?
5. What did the manufacturer, distributor or importer do to warn patients or healthcare professionals? Was there a safety communication from FDA? If so, provide the date it was issued and hyperlink to the safety communication. Provide a link to any company material that will provided to a patient.
6. How many devices are affected by the recall?
7. When were the devices manufactured? When was the manufacturer first notified of the problem that lead to the Class I recall? Is there a proposed end date for the Class I recall?
8. What are the proposed fixes? Workarounds? Will patients be provided with replacements? Will healthcare facilities be provided with replacements?
9. Provide any other information you believe is pertinent regarding why the Class I recall was initiated.
Format
The submission should be a 3,000-word paper (not including cover page) in Narrative (3rd Person) format in APA citing sources. Must be in APA format.
•Must cite all sources
•Must have alignment (Headers & Sub-Headers)
•Key concepts must flow logically through the paper and a transition paragraph (Use Key Word Method)
•Use relevant sources that are current (unless seminal work is required) and are Peer Reviewed (NO OPEN SOURCE)
•Do not use the same source multiple times in sequential order
Must use at least three external sources from Peer-Reviewed Medical Journals (PRJ) within the past five years. Two submissions will be provided. The article should be original and not be plagiarized from other sources. It is also highly recommended that students use ReciteWorks (https://reciteworks.com) to check in-text citations match the reference list.