Class I

Medical Device Recall: Regard Dressing change kit, Item Number 800026006

ROi CPS LLC · November 20, 2023

Reason for Recall

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Distribution

US Nationwide distribution in the state of Louisiana.

States Affected

NATIONWIDE

Quantity Affected

1830 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0596-2024

Status: terminated

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