FDA-Device2022-07-27Class II
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
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
40 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2022Don't want to check this manually?
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