ZOLL QUATTRO Intravascular Catheter Kit Labeling Update for Potential Leaks
ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II medical device recall for a potential hazard (leaks from the catheter or tubing) where no illnesses or injuries have been reported. The score of 3 reflects the serious potential of a high-risk intravascular device while recognizing this addresses a theoretical risk without reported incidents.
Plain-English summary
ZOLL Circulation, Inc. is updating the labeling for the QUATTRO Intravascular Heat Exchange Catheter Kit (Model 8700-0783-03, all lot numbers) to alert users to potential leaks from the catheter or start-up kit (SUK) tubing. This is an FDA Class II medical device recall involving 1,733 units.
The update was issued to inform users of the potential leak hazard associated with these devices.
The affected product has been distributed worldwide, including to all 50 U.S. states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
Healthcare facilities and providers with affected units should review the updated labeling from ZOLL Circulation and follow any instructions provided regarding this hazard.
The recalled product
- Product
- Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 1,733
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
Part of a larger recall action
This product is one of 28 recalled by ZOLL Circulation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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