Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Labeling Update for Leak Risk
ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a risk-of-harm product—potential leaks in an intravascular catheter could affect critical infusion therapy—but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
ZOLL Circulation, Inc. is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (REF 8700-0783-14, IC-4593CO). This is a 3-lumen, heparin-coated sterile medical device used for intravascular heat exchange with central venous infusion capabilities. Approximately 188 units across all lots have been distributed.
The labeling update addresses a potential risk of leaks from the catheter or start-up kit (SUK) tubing. No illnesses or injuries have been reported in relation to this concern.
The affected product has been distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
The recalled product
- Product
- Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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