FDA-Device2015-10-14Class II
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation Llc
Hazard
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Sold states
Distribution was made to LA, MS, and TX.
Affected count
1,476 kits
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2016Don't want to check this manually?
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