The Recall Desk
HighFDA (Devices)·Z-0058-2022·Announced 2021-10-13

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.

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: 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
  • 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