The Recall Desk
HighFDA (Devices)·Z-0062-2022·Announced 2021-10-13

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.

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 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.
Category
Medical Device — Extracorporeal Circulation
Hazard
  • tubing-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.

Related recalls

Same category