Z-2107-2025 Class II Ongoing
FDA device recall Z-2107-2025 was initiated by Preat Corp on June 24, 2025 and is designated Class II. Reason for recall: Due to manufacturing error, digital analog rotational feature is 180 degrees off. The recall status is ongoing. Affected quantity: 44 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2025
- Initiation Date
- June 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units
Product Description
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Reason for Recall
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Code Information
Lots: 278735, & 278402/UDI: