Recall Z-0063-2022— ZOLL Circulation, Inc.

Name: FDA recall Z-0063-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Class II · Terminated

Class II FDA medical device recall by ZOLL Circulation, Inc., initiated 2021-08-06, terminated 2024-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer. Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.

Recalling firm: ZOLL Circulation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-06
Terminated: 2024-10-18
Firm location: San Jose, CA, United States

Product description

Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Reason for recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

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