Zoll Quattro IV Disposable Packs and Kits Recalled for Potential Leaks
ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 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: Classified as FDA Class II and addressing a potential leak hazard in a medical device with no reported illnesses or injuries. This fits the rubric criterion of risk-of-harm products without reported injury.
Plain-English summary
ZOLL Circulation, Inc. has issued a labeling update for the Quattro IV Disposable Pack and Start-Up Kit (6 ft.), Reference Number 8700-000867-01. This is a Class II medical device used for circulation support.
The labeling update addresses a potential hazard: leaks may occur from the catheter or the start-up kit tubing. All lots of the product are affected.
334 bundles have been distributed nationwide in the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
Healthcare facilities and healthcare providers should contact ZOLL Circulation, Inc. for updated labeling and information on how to address the potential leak hazard.
The recalled product
- Product
- Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
- Manufacturer
- ZOLL Circulation, Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 334
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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