Recall Z-1295-2022— ROi CPS LLC

Name: FDA recall Z-1295-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Class II · Terminated

Class II FDA medical device recall by ROi CPS LLC, initiated 2022-05-20, terminated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.. Reason: A nonsterile component was packaged in a sterile convenience kit..

Recalling firm: ROi CPS LLC
Classification: Class II
Status: Terminated
Initiated: 2022-05-20
Terminated: 2023-05-02
Firm location: Republic, MO, United States

Product description

regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

Reason for recall

A nonsterile component was packaged in a sterile convenience kit.

Data sourced from openFDA. This site is unofficial and independent of the FDA.