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.
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: 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.
- Hazard
- product-leak
- device-defect
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.
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