The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0063-2022·Announced 2021-10-13

Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks

ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Class II medical device with potential for harm but no reported illnesses or injuries. Described as a 'labeling update concerning potential leaks,' indicating a precautionary measure without confirmed adverse events.

Plain-English summary

ZOLL Circulation, Inc. has recalled the Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit, model REF 8700-000869-40. The recall concerns a labeling update related to potential leaks from the catheter or the start-up kit tubing.

The recall affects 144 bundles of the product. The affected kits are 6-foot EU-model devices with New Luer connectors. All lot numbers are included in this recall.

The product has been distributed worldwide, including across the United States and in Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

The recalled product

Product
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Cooling Catheter
Hazard
Affected units
144

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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