FDA Enforcement
Class II
Terminated
eSuction Small Cavity, Model ET2005
Recall: Z-0270-2023
·
Reported November 30, 2022
Enforcement
- Recall Number
- Z-0270-2023
- Event ID
- 91074
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Endo-Therapeutics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 30, 2022
- Initiation Date
- October 24, 2022
- Classification Date
- November 18, 2022
- Termination Date
- January 24, 2024
- Address
- 15201 Roosevelt Blvd Ste 104, N/A, Clearwater, FL, 33760-3559, United States
Description
eSuction Small Cavity, Model ET2005
Reason
Improper device regulatory classification
Code Info
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Distribution
US distribution to Florida and Pennsylvania
Quantity
28 devices