Zoll Quattro IVTM Disposable Pack and Start UP Kit Potential Leak Hazard
ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.
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: FDA Class II recall involving potential leaks in IV delivery components that pose a risk of harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
ZOLL Circulation, Inc. is updating labeling for the Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.), reference number 8700-000766-01, due to a potential hazard involving leaks from the catheter or start-up kit tubing.
This labeling update applies to all lots of the affected product. The product was distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
Healthcare providers and facilities using this product should review the updated labeling for information regarding the potential leak hazard. Individuals or organizations with questions about this labeling update should contact ZOLL Circulation, Inc.
The recalled product
- Product
- Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
- Manufacturer
- ZOLL Circulation, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 16
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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