Device product
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Z-2107-2025
Product summary
- Firm
- Preat Corp
- Event
- Event 97136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-2107-2025
Official wording
Reason: Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Code information: Lots: 278735, & 278402/UDI:
Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Derived failure modes
-
Manufacturing or process control
manufacturing error