FDA Devices Moderate Class II Terminated

Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

Reported: October 13, 2021 Initiated: August 6, 2021 #Z-0065-2022

Product Description

Reason for Recall

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Details

Recalling Firm: ZOLL Circulation, Inc.
Units Affected: 579 bundled kits
Distribution: Worldwide distribution - US Nationwide distribution in the states of 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, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
Location: San Jose, CA

Frequently Asked Questions

What product was recalled? ▼

Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer. Recalled by ZOLL Circulation, Inc.. Units affected: 579 bundled kits.

Why was this product recalled? ▼

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0065-2022.