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Recall Observatory FDA recall evidence

Device product

Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

Z-0062-2022

August 06, 2021

Class II

Product summary

Firm
ZOLL Circulation, Inc.
Event
Event 88671
Status
Terminated
Classification
Class II
Quantity
79 bundles
Official record key
device-enforcement:Z-0062-2022

Official wording

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

Code information: All Lots

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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