Z-2443-2021 Class II Terminated
FDA device recall Z-2443-2021 was initiated by Hero Health on July 2, 2021 and is designated Class II. Reason for recall: Due to dispenser prompting for a missed dose that had already been dispensed The recall status is terminated (terminated November 2, 2023). Affected quantity: 12,039 units which had software version V2.04.012.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 2, 2021
- Termination Date
- November 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,039 units which had software version V2.04.012
Product Description
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Reason for Recall
Due to dispenser prompting for a missed dose that had already been dispensed
Distribution Pattern
U.S. Nationwide distribution.
Code Information
Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4