FDA-Device2022-07-06Class II

regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

ROi CPS LLC
Hazard

A nonsterile component was packaged in a sterile convenience kit.

Sold states
US Nationwide distribution in the state of FL.
Affected count
180 kits
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2022

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