Recall Z-2653-2020— Carefusion 2200 Inc

Name: FDA recall Z-2653-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-28

Class II · Terminated

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2020-05-28, terminated 2024-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Thora-Para 8 Fr Catheter Drainage Tray. Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Terminated
Initiated: 2020-05-28
Terminated: 2024-09-20
Firm location: Vernon Hills, IL, United States

Product description

Thora-Para 8 Fr Catheter Drainage Tray

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

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