FDA-Device2024-08-28Class II

Regard Kit containing the Microtek decanter

ROi CPS LLC
Hazard

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

Sold states
US Nationwide distribution in the state of MO.
Affected count
78 Kits
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard Kit containing the Microtek decanter

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2024

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