FDA-Device2021-05-19Class II

Regard Dressing Change Tray

ROi CPS LLC
Hazard

ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

Sold states
US Nationwide distribution in the state of Louisiana.
Affected count
272 trays
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard Dressing Change Tray

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2021

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