Summary
The FDA issued a Class II for eSuction Small Cavity, Model ET2005 by Endo-Therapeutics, Inc.. Reason: Improper device regulatory classification.
Details
Source
Device Recall
External ID
Z-0270-2023
Action Date
2022-11-30
Status
Terminated
Category
device
Product Description
eSuction Small Cavity, Model ET2005
Lot/Code Info: Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Quantity Affected: 28 devices
Reason for Recall
Improper device regulatory classification
Distribution
US distribution to Florida and Pennsylvania
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-24
Company
Clearwater, FL
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Endo-Therapeutics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Endo-Therapeutics, Inc. have FDA actions?
This is the only FDA action we have on record for Endo-Therapeutics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0270-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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