Summary
The FDA issued a Class II for DeRoyal BIOPSY PACK, REF 89-9270.05 by DeRoyal Industries Inc. Reason: XXX.
Details
Source
Device Recall
External ID
Z-0644-2023
Action Date
2022-12-21
Status
Ongoing
Category
device
Product Description
DeRoyal BIOPSY PACK, REF 89-9270.05
Lot/Code Info: Lot Numbers: Lot 57119598 exp 8/1/2024; Lot 57754111 exp 10/1/2024
Quantity Affected: 1200 kits
Reason for Recall
XXX
Distribution
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-03
Company
Powell, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 474 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeRoyal Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeRoyal Industries Inc have FDA actions?
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0644-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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