The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0040-2022·Announced 2021-10-13

Zoll Intravascular Catheter Kit Labeling Update for Potential Leaks

ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits 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 FDA Class II medical device presents a risk of harm through potential catheter or tubing leaks, with no reported injuries to date. It meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ZOLL Circulation, Inc. is issuing a labeling update for the REF 8700-0791-01 Premium Access Kit QUATTRO, an intravascular heat exchange catheter kit with central venous infusion capabilities. This sterile, single-use medical device is designed for femoral vein insertion.

This FDA Class II recall addresses a labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.

The labeling update affects 1,253 kits distributed worldwide, including all U.S. states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots of the product are included in this recall.

Recipients of this product should contact ZOLL Circulation, Inc. or consult the updated labeling for information regarding the potential leak risk and any recommended precautions.

The recalled product

Product
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
1,253

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.

The notice also names 37 states specifically:

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.

See all 28 products in this recall →

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