FDA-Device2024-01-10Class I
Regard Dressing change kit, Item Number 800026006
ROi CPS LLC
Hazard
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Sold states
US Nationwide distribution in the state of Louisiana.
Affected count
1830 units
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard Dressing change kit, Item Number 800026006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2024Don't want to check this manually?
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