FDA Enforcement
Class II
Ongoing
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Recall: Z-2107-2025
·
Reported July 16, 2025
Enforcement
- Recall Number
- Z-2107-2025
- Event ID
- 97136
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Preat Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 16, 2025
- Initiation Date
- June 24, 2025
- Classification Date
- July 10, 2025
- Address
- 2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States
Description
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Reason
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Code Info
Lots: 278735, & 278402/UDI:
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Quantity
44 units