Summary
The FDA issued a Class II for LYFO-DISK, P. venetum, Catalog number 0794L by Microbiologics Inc. Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus..
Details
Source
Device Recall
External ID
Z-0308-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
LYFO-DISK, P. venetum, Catalog number 0794L
Lot/Code Info: UDI/DI 10845357019186, Lot Numbers: 794-142-1
Quantity Affected: 3 units
Reason for Recall
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Distribution
Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-18
Company
Saint Cloud, MN
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 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
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 (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0308-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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