FDA-Device2020-12-09Class II
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
ROi CPS LLC
Hazard
Labeling error, incorrect expiration date.
Sold states
US Nationwide distribution in the states of MO and OK.
Affected count
220 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2021Don't want to check this manually?
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