Recall Z-0059-2022— ZOLL Circulation, Inc.
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 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.). 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 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
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.