The Recall Desk
HighFDA (Devices)·Z-0065-2022·Announced 2021-10-13

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.

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: 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.
Category
Medical Device — Intravenous Therapy Equipment
Hazard
  • leak
  • device-malfunction

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.

Related recalls

Same category