ZOLL Solex 7 IV Disposable Kit Recalled for Potential Catheter and Tubing Leaks
ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles 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 addressing a functional hazard—potential leaks in extracorporeal circulation tubing. No illnesses or injuries have been reported, which limits the severity to a High rating per rubric criteria for hazards without documented patient harm.
Plain-English summary
ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit (6 ft.), a medical device used in extracorporeal circulation procedures. The recall affects 79 bundles across all manufacturing lots, identified by reference number 8700-000868-01.
The recall was prompted by potential leaks in the catheter or start-up kit tubing. The FDA classified this as a Class II recall.
The product was distributed worldwide, covering all 50 U.S. states as well as Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
The recalled product
- Product
- Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 79
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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