Recall Z-0055-2022— ZOLL Circulation, Inc.
Class II · Terminated
Class II FDA medical device recall by ZOLL Circulation, Inc., initiated 2021-08-06, terminated 2024-10-18. It names one FDA 510(k) clearance: K150046. Product: Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
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.