TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Power Over Fiber Base Module
Check your package for
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
- Why
- 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
- Distributed
- U.S. Nationwide Distribution and International Distribution
- Company
- Terex Utilities
- Announced
- Recall began