Zoll ICY Heparin Disposable Infusion Kits Recalled Due to Potential Leaks
ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.
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 with no reported illnesses or injuries. The hazard—potential leaks from infusion tubing—presents a risk of harm to patients, meeting the criterion for High (3) severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ZOLL Circulation, Inc. is recalling approximately 1,122 ICY (Heparin) IVTM Disposable Pack and Start UP Kit units (Model REF 8700-000870-40) with EU New Luer connector, distributed worldwide including across all US states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots are affected by this recall.
The recall addresses labeling concerns regarding potential leaks from the catheter or the start-up kit (SUK) tubing. No illnesses or injuries related to this issue have been reported.
Affected customers should obtain and review the updated labeling from ZOLL Circulation, Inc. to understand the potential leak risk and ensure proper handling of the infusion kits.
The recalled product
- Product
- Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
- Manufacturer
- ZOLL Circulation, Inc.
- Affected units
- 1,122
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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