United StatesPower Over Fiber Base Module from Terex Utilities (identifiers P/N 633232, P/N 622365, P/N 633383, P/N 633910, P/N 635731) sold nationwide in the U.S. and internationally. It was recalled because the device was not certified (no laser product report filed with CDRH), the label incorrectly states “Class IV” though Class 1 is appropriate, required labels and compliant user information were missing, and formal quality control procedures and record keeping to IEC 60825-1 and 21 CFR 1040.10 were not performed.
What's being recalled
Power Over Fiber Base Module
Recalling firm: Terex Utilities, Watertown, SD, United States.
How to identify it
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
The hazard
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide Distribution and International Distribution
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)