The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0059-2022·Announced 2021-10-13

Zoll Cool Line IV Disposable Pack Recalled for Potential Leakage Risk

ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.

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 is an FDA Class II medical device recall concerning potential leaks in an intravenous catheter system. Although no illnesses or injuries have been reported and the hazard is described as potential, the product is a critical medical device where leaks could prevent proper medication delivery. Per the severity rubric, a risk-of-harm product where injury has not yet been reported warrants a High (3) rating.

Plain-English summary

ZOLL Circulation Inc. is recalling the Cool Line IV Disposable Pack and Start UP Kit (REF 8700-000865-01), a medical device for intravenous therapy. A labeling update has been issued concerning potential leaks from the catheter or the start-up kit tubing. This recall affects all lots of the product.

The recalled product was distributed both domestically and internationally, including to healthcare facilities across the United States and to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. A total of 55 bundles are affected by this recall.

Healthcare providers and facilities should verify their inventory and contact ZOLL Circulation Inc. for instructions. Patients currently using this device should speak with their healthcare provider about this recall and any necessary precautions or alternative treatments.

The recalled product

Product
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravenous catheter system
Hazard
Affected units
55

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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