ROi CPS LLC recalls Isolation Droplet Bundle Kit

Recall date

May 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2465-2020

FDA classification

Class II

Brand / firm

ROi CPS LLC

Sold / distributed

Domestic distribution only to: MO and LA.

Why it was recalled

Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Isolation Droplet Bundle Kit