FDA-Device2025-07-16Class II

Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Preat Corp
Hazard

Due to manufacturing error, digital analog rotational feature is 180 degrees off.

Sold states
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Affected count
44 units
Manufactured in
2625 Skyway Dr Ste B, N/A, Santa Maria, CA, United States
Products
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2025

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