ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks
ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard involves potential leaks, but without confirmed incidents of harm, this constitutes a precautionary labeling update.
Plain-English summary
ZOLL Circulation, Inc. is issuing a labeling update for the SOLEX 7 Intravascular Heat Exchange Catheter Kit (REF 8700-0793-40, Model SL-2593AE), a medical device intended for intravascular temperature management with heparin-coated central venous infusion capabilities. The update addresses potential leaks from the catheter or start-up kit (SUK) tubing.
The labeling update applies to all lots of the device, with 5,345 kits 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 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
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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