Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Reported: October 13, 2021 Initiated: August 6, 2021 #Z-0059-2022
Product Description
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
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
- 55 bundles
- 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 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.). Recalled by ZOLL Circulation, Inc.. Units affected: 55 bundles.
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-0059-2022.
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