FDA-Device2022-07-27Class II
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
ROi CPS LLC
Hazard
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Sold states
Distribution was made to MO. There was no foreign/military/government distribution.
Affected count
86 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2022Don't want to check this manually?
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