ZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks
ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled 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: FDA Class II medical device recall with potential leak hazard in intravenous therapy equipment. No reported illnesses or injuries mentioned in the source. Meets criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ZOLL Circulation, Inc. is recalling the Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (Model REF 8700-000871-40, 6 ft., EU, New Luer) due to potential leaks from the catheter or start-up kit tubing. A labeling update has been issued to address this concern.
The recall affects 579 bundled kits with all lot numbers included. The affected kits were distributed worldwide, including across the United States in the following states: AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV. International distribution includes Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
If you have received this product, review the updated labeling provided by ZOLL Circulation, Inc. and follow any new instructions regarding proper use and handling. Contact the manufacturer directly with any questions or concerns about the potential leak risk.
The recalled product
- Product
- Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 579
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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