Z-0270-2023 Class II Terminated
FDA device recall Z-0270-2023 was initiated by Endo-Therapeutics, Inc. on October 24, 2022 and is designated Class II. Reason for recall: Improper device regulatory classification The recall status is terminated (terminated January 24, 2024). Affected quantity: 28 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 24, 2022
- Termination Date
- January 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 devices
Product Description
eSuction Small Cavity, Model ET2005
Reason for Recall
Improper device regulatory classification
Distribution Pattern
US distribution to Florida and Pennsylvania
Code Information
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204