FDA Device

eSuction Small Cavity, Model ET2005

Hazard

Improper device regulatory classification

What You Should Do

Remedy

Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form.

Products

eSuction Small Cavity, Model ET2005
Brand
Endo-Therapeutics, Inc.
UPC
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204

Units Affected

28 devices